BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX GR 1 X 30 CV301 5/0 DA 1% SS

    MDR report key: 629339 · Received August 22, 2005

    Report

    Report Number
    9681850-2005-00018
    Event Type
    Injury
    Date Received
    August 22, 2005
    Date of Event
    July 5, 2005
    Report Date
    July 26, 2005
    Manufacturer
    GOSPORT-USS
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED IN AN UNSPECIFIED PROCEDURE. THE RUNNING SUTURE OF AN APONEUROSIS DID NOT HOLD CAUSING AN EVISCERATION. RE-OPERATION OCCURRED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAX GR 1 X 30 CV301 5/0 DA 1% SS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE GAN GOSPORT-USS NA E5D0321C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2