BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX AB ASSEMBLY - CURVED

    MDR report key: 6113951 · Received November 18, 2016

    Report

    Report Number
    1219602-2016-01266
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 27, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K151105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE COMPLAINT, IT WAS NOTICED THAT THE DEPLOYMENT HAPPENED OUTSIDE OF THE POUCH/PACKAGING. REPORTING HAS BEEN UPDATED FOR THIS COMPLAINT, AS IT IS NOW NON-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR HAD BEEN PRE-DEPLOYED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764024 ULTRA FAST-FIX AB ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50596552

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR