BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFFRON FIXATION TOOL

    MDR report key: 19719688 · Received July 11, 2024

    Report

    Report Number
    2125050-2024-01021
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 11, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    PMA / PMN Number
    K220420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHOR PULLED OUT ON THE RIGHT-SIDE DURING TIE-DOWN. A CAPIO DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379660 SAFFRON FIXATION TOOL SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown