BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 25125952 · Received May 8, 2026

    Report

    Report Number
    8021545-2026-06551
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER ENTITY: ABBVIE INC. COUNTRY: UNITED STATES. STREET: 1 NORTH WAUKEGAN ROAD. CITY: NORTH CHICAGO. STATE: ILLINOIS. ZIP CODE: 60064. 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

    THE PATIENT REPORTED A REDNESS, INFLAMMATION AT THE INJECTION SITE ON THE LEFT UPPER ARM. AT THIS SITE, SHE HAD A PUMP INSTALLED FOR PARKINSON'S DISEASE THERAPY (PRODUODOPA), CONSEQUENTLY SHE DEVELOPED AN ABSCESS WHICH WAS SURGICALLY TREATED. AND THE DOCTOR PRESCRIBED ANTIBIOTICS TREATMENT WITH BETAKLAV (AMOXICILLIN/CLAVULANIC ACID) ON (B)(6) 2026, HOWEVER NO MALFUNCTION RELATED TO INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31594 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown