BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP® INSET

    MDR report key: 19565552 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-09043
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Report Date
    July 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1891989 - MDR 3003442380-2024-09043- DEVICE 2 OF 4.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4). THE FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES OF LOT 6005149. 1. VISUAL INSPECTION AS PER (B)(6) QUALITY CRITERIA FOR PRODUCTS OF THE INSET FAMILY ENGESP (CRITERIOS DE CALIDAD PARA PRODUCTOS DE LA FAMILIA INSET ENGESP), VERSION 40. 10 SAMPLES VISUALLY INSPECTED AND NO DAMAGES OR BENT.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRIA. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF BECAUSE ADHESIVE DID NOT WORK. THE ISSUE OCCURRED AFTER 24 HOURS OF USE. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703236 YPSOPUMP® INSET UNO INSET II 60/9 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-060-52B9 6005149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male