BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3172660 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05315
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE IMPLANTATION OF THE PINNACLE ON (B)(6) 2010 TOOK PLACE AT (B)(6). HOWEVER, IT WAS NOT INDICATED WHICH PHYSICIAN CORRESPONDS TO THE IMPLANTATION OF THE PINNACLE DEVICE, AND WHICH CORRESPOND TO THE IMPLANTATION OF THE OBTRYX AND XENFORM DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272841 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other