BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLCARE

    MDR report key: 21025982 · Received December 27, 2024

    Report

    Report Number
    21025982
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    September 27, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ALLCARE, INC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    HAIR FOUND IN STERILE LAP SPONGE PACK. MANUFACTURER RESPONSE FOR STERILE LAPAROTOMY SPONGE, (BRAND NOT PROVIDED) (PER SITE REPORTER). A NO CHARGE REPLACEMENT PROVIDED. REPORTED BUT NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365889 ALLCARE GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY ALLCARE, INC AL1818 21XC05

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male