BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDAGE KIT, COMPRESSION COMPRI2 LITE 9 3/4IN X 12 1/2IN

    MDR report key: 25318454 · Received May 28, 2026

    Report

    Report Number
    MW5188662
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 10, 2026
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    FQM
    UDI-DI
    04042809506679
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT: (B)(4): LLT CODES: 10069327:PRODUCT QUALITY ISSUE I NARRATIVE: PRODUCT PROBLEM: VETERAN REPORTED TO NURSE THAT THE LAST 2 SHIPMENTS OF COMPRI2 LITE COMPRESSION WRAPS HAVE SMELLED MOLDY WHEN THEY OPEN THE BOX. HE SAYS THEY DON'T LOOK MOLDY, BUT THE SMELL IS NOTICEABLE ESPECIALLY WHEN OPENING THE WHITE WRAP. HE REPORTED HE USED ONE OF THE SET BUT IT CAUSED ITCHING AND INFLAMMATION SO HE REMOVED IT. PHARMACY WILL SEND REPLACEMENT SUPPLY AS REQUESTED. PATIENT HAS USED THIS SUPPLY ITEM SINCE 2025. NO PRIOR COMPLAINTS RECEIVED WITHIN PHARMACY. DIAGNOSIS FOR USE: COMPLEX SIG ORDER (PROD 1): USE BANDAGE TOPICALLY EVERY 96 HOURS FOR COMPRESSION. PT: 1943, 1932. DEVICE: 2969, 1425. REF: MW5188663.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536066 BANDAGE KIT, COMPRESSION COMPRI2 LITE 9 3/4IN X 12 1/2IN BANDAGE, ELASTIC FQM BSN MEDICAL, INC. 540264 04042809506679

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male