BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24906964 · Received April 17, 2026

    Report

    Report Number
    8021545-2026-86839
    Event Type
    Injury
    Date Received
    April 17, 2026
    Report Date
    March 23, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NAME: ABBVIE INC STREET: 1 NORTH WAUKEGAN ROAD CITY: NORTH CHICAGO STATE: IL ZIP CODE: 60064. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE SERIOUS INJURY. 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 DEVELOPED INFECTION AND HAD STARTED ORAL ANTIBIOTICS (AUGMENTIN 875MG) TO TREAT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111795 OTHER ACCESSORIES INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN ICD 6016618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown