BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNBRANDED

    MDR report key: 23423532 · Received October 30, 2025

    Report

    Report Number
    23423532
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE NURSE WAS IN THE CLEAN SUPPLY ROOM TO SELECT A "WEDGE PRESSURE DRESSING" TO APPLY AFTER A FEMORAL LINE WAS PULLED- WHEN SHE DID A CLOSER EXAMINATION OF THE PACKAGE, SHE NOTED A HUMAN HAIR WITHIN (INSIDE OF) HE SEALED STERILE PACKAGING- THE PACKAGE WAS NOT OPENED AND WAS SEQUESTERED - PHOTOS AVAILABLE UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297086 UNBRANDED DRESSING, WOUND, DRUG FRO ADVANCE MEDICAL DESIGNS, INC. 2019 41017C4479

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male