BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C ARM DRAPE

    MDR report key: 21945402 · Received May 1, 2025

    Report

    Report Number
    MW5169779
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 29, 2025
    Manufacturer
    UNKNOWN
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    C- ARMOR DRAPE AROUND C ARM SPLIT WHILE IN USE OVER THE PATIENT MID PROCEDURE. PRODUCT REF: (B)(6). LOT: 65063219. EXPIRATION: 12-23-2029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479729 C ARM DRAPE DRAPE, SURGICAL KKX UNKNOWN 5536 65063219

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other