BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 25266287 · Received May 23, 2026

    Report

    Report Number
    8021545-2026-09649
    Event Type
    Injury
    Date Received
    May 23, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME: (B)(6) BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE SERIOUS INJURY. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545 MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE MULTIPLE SKIN NODULES ON THE ABDOMEN AT DIFFERENT INJECTION SITES SUCH AS THE THIGHS AND ARMS WHICH LED TO REDNESS ON THE ABDOMEN HAS DEVELOPED INTO AN ABSCESS WHILE USING NERIA GUARD DAILY AND THE PHYSICIAN PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87026 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown