BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN 3/0 27 UNDYED C-14

    MDR report key: 3143119 · Received May 24, 2013

    Report

    Report Number
    1219930-2013-00403
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 9, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K000037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CARPAL CANAL SUTURE BECAME LOOSE AND FINALLY OPENED ITSELF. NEED FOR A REINTERVENTION ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231885 BIOSYN 3/0 27 UNDYED C-14 DISPOSABLE SURGICAL ACCESS DEVICE GAM COVIDIEN, FORMERLY US SURGICAL B2D0962X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other