BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH V PATCH

    MDR report key: 9391819 · Received November 27, 2019

    Report

    Report Number
    MW5091357
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    August 27, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CHRONIC ABDOMINAL PAIN SINCE VENTRAL HERNIA REPAIR WITH ATRIUM C-QUR MESH IN 2011 REQUIRING MULTIPLE ED / HOSP ADMISSIONS, CT IMAGING, MULTIPLE MEDICATIONS. SURGERY WAS DONE ON (B)(6) 2019 FOR C-QUR MESH REMOVAL, AND REDO HERNIA REPAIR WITH MESH. OPERATIVE FINDINGS REVEALED THAT THE C-QUR MESH RETRACTED INTO A MESH BALL. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181972 C-QUR MESH V PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 10752171075

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| S