BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 25031490 · Received April 29, 2026

    Report

    Report Number
    8021545-2026-05362
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 2, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 A 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

    ITS WAS REPORTED THAT THE PATIENT FACED INFECTION AT INSERTION SITE ON (B)(6) 2026 AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090171 OTHER ACCESSORIES Set, administration, intravascular FPA UNOMEDICAL DEVICES S.A DE C.V INFUSION DEVICES - UNKNOWN ICD 6010977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown