BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONODEK SUTURE BN

    MDR report key: 2181063 · Received July 7, 2011

    Report

    Report Number
    1018233-2011-00169
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 10, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    NEW
    PMA / PMN Number
    K030212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BARD HAS MADE 5 ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE CUSTOMER WITHOUT ANY SUCCESS. THE ACTUAL SAMPLE REMAINS IN THE PATIENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALLEGED BY THE FACILITY THAT THE SUTURING DEVICE DID NOT FIRE THE SUTURE PROPERLY INTO THE PATIENT'S LIGAMENT RESULTING IN THE SUTURE BULLET BRAKING OFF IN THE PATIENT. THE BULLET TIP WAS LEFT IN THE PATIENT WITH NO INTERVENTION TAKEN FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONODEK SUTURE BN NEW C.R. BARD, INC. NA 0201103012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK