BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 2091843 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01653
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN SLING WAS USED DURING A SLING PLACEMENT PROCEDURE ON (B)(6), 1998. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN, A PELVIC ABSCESS, VAGINAL BLEEDING, PURULENT BLEEDING, HEMATURIA, PYURIA, AND INTERSTITIAL CYSTITIS. THE EXACT DATE OF ONSET FOR EACH IS UNKNOWN. IN (B)(6) 2010, THE PATIENT HAD THE SLING REMOVED. ALL OTHER EVENT DETAILS, INCLUDING THE PATIENT CONDITION AT THE CONCLUSION OF THE INITIAL PROCEDURE AND THE PATIENT'S CURRENT CONDITION, ARE UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention