-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CHEpYUrlgFHlDbREGT6dJQe7q1kzaBy6aCUPNZc5SQRAa108r2r067lOftHWpU+F RfgNiSs6biaVJD4b40FXvA== 0001096906-04-000331.txt : 20040812 0001096906-04-000331.hdr.sgml : 20040812 20040812134131 ACCESSION NUMBER: 0001096906-04-000331 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040811 ITEM INFORMATION: Other events FILED AS OF DATE: 20040812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UTAH MEDICAL PRODUCTS INC CENTRAL INDEX KEY: 0000706698 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 870342734 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12575 FILM NUMBER: 04969648 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k081204.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (date of earliest event reported): August 11, 2004 Commission File No. 0-11178 ------- UTAH MEDICAL PRODUCTS, INC. --------------------------- (Exact name of Registrant as specified in its charter) UTAH 87-0342734 ------------------------------- ------------------ (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 7043 South 300 West Midvale, Utah 84047 ------------------- Address of principal executive offices Registrant's telephone number: (801) 566-1200 -------------- - -------------------------------------------------------------------------------- ITEM 5. OTHER EVENTS - -------------------------------------------------------------------------------- On August 11, 2004, Utah Medical Products, Inc. issued a press release comprised of a letter from Chairman and CEO Kevin L. Cornwell to UTMD's customers regarding the current FDA situation. A copy of the press release is attached hereto as Exhibit 99.1 - -------------------------------------------------------------------------------- SIGNATURES - -------------------------------------------------------------------------------- Pursuant to the requirements of the Securities Exchanges Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. UTAH MEDICAL PRODUCTS, INC. REGISTRANT Date: 8/12/2004 By: /s/ Kevin L. Cornwell ------------------------ -------------------------- Kevin L. Cornwell CEO - -------------------------------------------------------------------------------- EXHIBIT INDEX Index Number Description - ------ ----------- 99.1 Press release issued August 11, 2004: Utah Medical Products, Inc. Sends Letter to Its Customers. EX-99.1 2 utahmed8k081204ex99-1.txt EXHIBIT 99.1 Salt Lake City, Utah - The following letter is being sent to Utah Medical Products, Inc. (NASDAQ:UTMD) customers from Chairman and CEO Kevin Cornwell: I want to express some frank words about Utah Medical Products, Inc.'s (UTMD's) current experience with the Food and Drug Administration ("FDA"), and some explanation regarding a dispute that is now public. All medical device manufacturers are subject to regulation by the Food and Drug Administration. This includes inspection of manufacturing facilities by FDA employees, most of whom have never had a responsibility to manufacture a device or experience in the manufacturing of a device. Everyone; manufacturers, clinical users and patients; benefit from an agency that is competent and strong. Since 2001, UTMD has been subject to repeated and extensive inspection by these FDA employees. While their observations often represent unqualified opinions which are not backed by law or regulation, at no time has there ever been any evidence to support a concern about either the safety or effectiveness of our devices. Although we have consistently responded comprehensively in writing to inspectors' observations, FDA supervisory and management personnel have refused for nearly three (3) years to engage in dialogue with UTMD that would identify a violation of the Quality System Regulation (QSR), also known as GMPs (Good Manufacturing Practices). A variety of independent experts have been retained by UTMD to evaluate our manufacturing practices. They have concluded that UTMD does comply with a reasonable interpretation of applicable laws and regulations, including the QSR. UTMD is comforted by this fact, and welcomes the opportunity presented by the recent complaint filed by the FDA to confirm through a trial process what our reputation over twenty-five (25) years has established; namely, that clinician users can rely on the quality and performance of UTMD's devices. Despite the FDA publicized complaint, there is no restriction placed on UTMD to limit manufacture or distribution of any of its devices. Ironically, a key distinction of UTMD's products proven clinically over the years is that our quality products help reduce risk. The confidence that you have displayed in our devices is sincerely appreciated. I assure you that UTMD neither has nor will it diminish its commitment to manufacture devices of the greatest quality. Please reflect on your personal experience using our products, and continue to give us your support. In summary, * There are no restrictions limiting your use of UTMD's products. There are no restrictions limiting our manufacture or distribution of products. * FDA claims have to be formally adjudicated. UTMD is innocent until proven otherwise. We regret it if the FDA's public statements give an unfair implication of guilt. * There has never been, nor is there now, an FDA allegation that UTMD's products are not safe and effective. Sincerely, Kevin L. Cornwell Chairman and CEO -----END PRIVACY-ENHANCED MESSAGE-----