BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED

    MDR report key: 24801103 · Received April 7, 2026

    Report

    Report Number
    MW5186438
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 2, 2026
    Manufacturer
    INTEGRATED MEDICAL SYSTEMS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HAIR WAS DISCOVERED IN A PACKAGE OF 20ML STERILE COMPOUNDING SYRINGE. ITEM THEN WAS PULLED FROM THE STERILE COMPOUNDING ROOM. BATCH OF ITEMS IS QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237087 IMED SYRINGE, PISTON FMF INTEGRATED MEDICAL SYSTEMS, INC. IM54089 D2505049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown