BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KITTMANN DEFIBRILLATOR PAD

    MDR report key: 33683 · Received June 21, 1996

    Report

    Report Number
    MW1009356
    Event Type
    Injury
    Date Received
    June 21, 1996
    Report Date
    June 19, 1996
    Manufacturer
    MEDICAL PRODUCTS GROUP 3M CO.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DEFIB-PADS CONTAIN ONLY DATE OF MFR, NOT EXP DATE. PRODUCT IN RPTR'S ASU-MFR 1/85 QUESTION ABOUT SHELF-LIFE. PROTOCOL IS 3 YRS - WHY IS THIS NOT INDICATED ON PACKAGING? PADS LOSE CONDUCTIVE CAPABILITIES. THE NEW PROD CONTAINS A 3 YR EXP DATE, BUT HOW WOULD PEOPLE KNOW TO DISCARD THE PREVIOUS PRODUCT? PERHAPS A RECALL - TO LET OTHERS KNOW PRODUCT # 2346 IS OBSOLETE SINCE 9/95 - AND REPLACE WITH #2346N?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KITTMANN DEFIBRILLATOR PAD DEFIBRILLATOR PAD LDD MEDICAL PRODUCTS GROUP 3M CO. 2346 96

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening