BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MESH

    MDR report key: 1780929 · Received August 2, 2010

    Report

    Report Number
    1780929
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    June 3, 2010
    Report Date
    July 21, 2010
    Manufacturer
    UNK
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6)2009 - LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING PROCEDURE DONE. ON (B)(6)2010 - LAP-BAND RESERVOIR WOUND DEHISCENCE. LAP-BAND RESERVOIR REVISION PERFORMED. ITEM INVOLVED IN A RECALL OF COUNTERFEIT SURGICAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL MESH FTM UNK 43HPD027

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention