BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24826811 · Received April 9, 2026

    Report

    Report Number
    8021545-2026-88900
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 7, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A 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 EXPERIENCED PSYCHIATRIC SYMPTOMS, HALLUCINATIONS, MOTOR FLUCTUATIONS AND SOME BEHAVIORAL CHANGES LIKE BITING ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887228 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown