BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-GRAVITY EQUIPMENT COVER

    MDR report key: 24433155 · Received February 24, 2026

    Report

    Report Number
    MW5184350
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Report Date
    February 19, 2026
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OPENED ZERO GRAVITY DRAPE (ITEM 191729) AND FOUND SPLICED PLASTIC AND MISSING VELCRO. UNABLE TO USE AS COVER FOR ZERO GRAVITY. SAVED ITEM AND PACKAGE, MARKED AS DEFECTIVE FOR CHARGING. LOT 72654927, REF ZGD20WA-LOOP. HAVE USED OTHERS FROM THIS LOT WITHOUT ISSUE, MANY OTHERS OF THIS LOT REMAIN ON THE SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499718 ZERO-GRAVITY EQUIPMENT COVER DRAPE, SURGICAL, EXEMPT PUI TIDI PRODUCTS, LLC ZGD20WA-LOOP 72654927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown