BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT CARE DIVISION

    MDR report key: 148469 · Received February 10, 1998

    Report

    Report Number
    MW1012975
    Event Type
    Malfunction
    Date Received
    February 10, 1998
    Report Date
    February 10, 1998
    Manufacturer
    ZIMMER PATIENT CARE DIVISION
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TOURNIQUET PORT TO AN ATS CYLINDRICAL TOURNIQUET CUFF BROKE OFF. THERE IS THE POTENTIAL FOR THE CUFF TO DEFLATE DURING SURGERY. THIS PROBLEM WAS ORIGINALLY REPORTED TO ZIMMER BY LETTER ON 8/1/97 AND THE DEFECTIVE CUFF WAS RETURNED. THE PROBLEM DESCRIBED IS THE SAME AS REPORTED IN FDA ENFORCEMENT REPORT DATED 7/2/97 RECALL #Z-679-682-7, BUT, THIS LOT NUMBER WAS NOT INCLUDED IN THE RECALL. RPTR HAS REQUESTED THE RESULTS OF THE CO'S EVALUATION BY LETTER, FAX AND TELEPHONE AND TO DATE HAVE NOT RECEIVED ANY FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT CARE DIVISION ATS CYLINDRICAL TOURNIQUET CUFF KCY ZIMMER PATIENT CARE DIVISION 60-7500-006 91823000

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other