BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFFRON ANCHOR

    MDR report key: 19968174 · Received August 12, 2024

    Report

    Report Number
    2125050-2024-01230
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 12, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    UDI-DI
    05708932757430
    PMA / PMN Number
    K220420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT # 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 PATIENT IS SUFFERING NERVE PAIN AFTER A PROLAPSE REPAIR WITH THE SAFFRON LIGAMENT FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247402 SAFFRON ANCHOR SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S 05708932757430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other