BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED MEDICAL ENDOCATCH INZII BAG

    MDR report key: 11824923 · Received May 13, 2021

    Report

    Report Number
    MW5101347
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    January 4, 2021
    Report Date
    May 11, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    [INVALID]ON THE BAG BROKE DURING TIGHTENING OF BAG APERTURE, NO APPARENT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717410 APPLIED MEDICAL ENDOCATCH INZII BAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. MFR# CD003 1378092

    Patients

    Seq Age Sex Outcome Treatment
    1