BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24906842 · Received April 17, 2026

    Report

    Report Number
    3003442380-2026-83262
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 18, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. 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: 3003442380.

    Description of Event or Problem · 0

    THE PATIENT REPORTED NODULES/BUMPS AT INFUSION SITES - AMOXICILLIN/CLAVULANIC ACID (875-125 MG, TWICE DAILY) AND PATIENT DEVICE INTERACTION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60949 OTHER ACCESSORIES Set, administration, intravascular FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN ICD 6013582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown