BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 3250113 · Received July 26, 2013

    Report

    Report Number
    3005099803-2013-07526
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRELEX MESH WAS IMPLANTED (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN¿S OFFICE, THE PATIENT HAD AN UNEVENTFUL PROCEDURE. THE PATIENT HAD A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2009 AND DID NOT SHOW UP. PHONE CALLS TO RESCHEDULE THE APPOINTMENT WERE NOT RETURNED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350424 MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other