BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX GR 1X60 T60 01

    MDR report key: 2202372 · Received August 3, 2011

    Report

    Report Number
    1219930-2011-00618
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 8, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: SUTURE BROKE AND THE PATIENT FASCIA DEHISCED. REOPERATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAX GR 1X60 T60 01 ABSORBABLE SYNTHETIC SUTURE GAM UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention