BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24994043 · Received April 26, 2026

    Report

    Report Number
    8021545-2026-04610
    Event Type
    Injury
    Date Received
    April 26, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 31, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF INVESTIGATION FINDINGS: CODE FOR FEELING OFF (PARKINSON PATIENT) IS NOT AVAILABLE IN DATABASE SO CLOSEST CODE (E020203 AND F12) HAS BEEN CAPTURED. E1: EVENT COUNTRY: NETHERLANDS. NAME: ABBVIE INC. COUNTRY: UNITED STATES OF AMERICA. STREET ADDRESS: 1 NORTH WAUKEGAN ROAD. CITY: NORTH CHICAGO. STATE: IL. ZIP CODE: 60064. 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 PATIENT FACED LEAKAGE AT CANNULA ON (B)(6) 2026. THE PATIENT HAS PARKINSON AND WAS FEELING OFF, ALSO HAD SITE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054911 OTHER ACCESSORIES UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown