BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRABRAID FAST-FIX AB CURVED NEEDLE DELIVERY SYS.

    MDR report key: 1070522 · Received July 1, 2008

    Report

    Report Number
    1219602-2008-00155
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 6, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MENISCAL REPAIR, IT WAS DIFFICULT TO ADVANCE AND DEPLOY T2 AFTER PLACING T1. T1 REMAINS UNSUPPORTED IN THE PT. THERE IS NO ADD'L INFO AVAILABLE AT THIS TIME. TWO LOTS WERE USED AND IT IS UNK WHICH LOT REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRABRAID FAST-FIX AB CURVED NEEDLE DELIVERY SYS. FAST-FIX AB- ULTRABRAID GAS SMITH & NEPHEW INC., ENDOSCOPY DIV. 72201494 50243191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK