BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI SUPERBAG SPECIMEN RETRIEVAL BAG

    MDR report key: 12532427 · Received September 24, 2021

    Report

    Report Number
    MW5104194
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 22, 2021
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAP CHOLE, WE WERE TRYING TO REMOVE THE GALLBLADDER WITH THE SUPERBAG. THE FIRST ONE MALFUNCTIONED AND WOULD NOT DEPLOY. THE SECOND ONE DEPLOYED BUT THE BAG RIPPED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427599 PMI SUPERBAG SPECIMEN RETRIEVAL BAG INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM PROGRESSIVE MEDICAL, INC. 2106PNI024002
    1427600 PMI SUPERBAG SPECIMEN RETRIEVAL BAG INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM PROGRESSIVE MEDICAL, INC. 2106PNI024002

    Patients

    Seq Age Sex Outcome Treatment
    1