BEUDAMED
    FDA Adverse Event Summary report: N

    GORILLA BAG

    MDR report key: 10239161 · Received July 6, 2020

    Report

    Report Number
    MW5095379
    Date Received
    July 6, 2020
    Date of Event
    May 11, 2020
    Report Date
    July 6, 2020
    Manufacturer
    HEALTHMARK INDUSTRIES CO., INC.
    Product Code
    FSM
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WET PACKS CAN INFECT PTS. GOT NEW PRODUCT THAT IS SUPPOSED TO PROTECT STERILE INSTRUMENTS. YOU PACKAGE AS NORMAL AND THEN PUT IN "GORILLA BAG" FROM HEALTHMARK THEN STERILIZE. IT DOESN'T WORK, MAKES WET PACKS. WHEN PACK OPENED HAS WATER, CAME TO FIND OUT WE HAVE IFU FOR PRODUCT FROM COMPANY BUT COMPANY NEVER TOOK PRODUCT THROUGH FDA 510K WHEN WE ASKED THEM, THEY SAID THEY DON'T NEED IT. HOW IS ANY PRODUCT USED TO STERILE INSTRUMENTS FOR SURGERY NOT RECEIVED BY 510K? EXPLAIN WHY THEY CAN SELL PRODUCT THAT DOESN'T WORK. GORILLA BAG MAKES WET PACKS CONSISTENTLY, WE OPENED ALL OF THEM. WET PACK CAUGHT BEFORE PT IN ROOM. REF DOCUMENTS: STERILIZATION WRAP(S) CONFORMING TO AAMI/ISO 11607, PARTS 1 AND 2, ISO/TS 16775.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695301 GORILLA BAG TRAY, SURGICAL, INSTRUMENT FSM HEALTHMARK INDUSTRIES CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other