BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 4407032 · Received January 5, 2015

    Report

    Report Number
    MW5040144
    Event Type
    Injury
    Date Received
    January 5, 2015
    Date of Event
    October 17, 2014
    Report Date
    January 5, 2015
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UPDATING MAUDE ADVERSE REPORT NUMBER MW5033098 (B)(6) 2013. THIS IS THE LAST 10% REPAIR OF THE PREVIOUS REPORTED INCIDENT. ON (B)(6) 2014 DR. (B)(6) OPERATION DEBRIDEMENT OF CHRONIC ABDOMINAL WOUND AND REMOVAL OF INFECTED MESH. THE REMOVAL OF THE INFECTED MESH WAS PERFORMED BY DR. (B)(6) SEPARATELY. PREOPERATIVE DIAGNOSIS: NONHEALING ABDOMINAL WOUND. THERE WAS CLEARLY SOME EXPOSED MESH RIGHT IN THE MIDDLE OF HER REPAIR. THERE WAS AN ASSOCIATED ABSCESS WITH SOME NON-INCORPORATED MESH WITHIN THIS POCKET. REMOVED INFECTED MESH IN ITS ENTIRETY. THIS MESH PARIETEX HAD BEEN IMPLANTED IN THE (B)(6) 2013 REPAIR AFTER REMOVING THE KUGEL MESH. DR. (B)(6) DRAINED THE ABSCESS AND INSERTED 2 DRAINS. THIS SHOULD BE THE LAST SURGERY NEEDED TO CORRECT THE KUGEL MESH INSERTED (B)(6) 2007. MW REPORT 5033098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3783 PARIETEX MESH OTP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R