BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IVS TUNNELLER DEVICE

    MDR report key: 6132844 · Received November 29, 2016

    Report

    Report Number
    6000141-2016-00013
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    July 7, 2005
    Report Date
    October 26, 2016
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    PMA / PMN Number
    K073164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PRE-OP DIAGNOSIS: BILATERAL PARAVAGINAL DEFECT, ENTEROCELE, CYSTOCELE, AND RECTOCELE. NAME OF PROCEDURE: BILATERAL PARAVAGINAL DEFECT REPAIRS, TRANSVAGINAL ENTEROCELE REPAIR, BILATERAL SACROSPINOUS LIGAMENT FIXATION, POSTERIOR REPAIR. STAGED INTERSTIM SACRAL NERVE IMPLANT PERFORMED ON (B)(6) 2009. PRE-OP AND POST-OP DIAGNOSIS: URGENCY, FREQUENCY, URGE URINARY INCONTINENCE. INSERTION OF TWIN IPG PERFORMED ON (B)(6) 2009. PRE-OP AND POST-OP DIAGNOSIS: URGENCY, FREQUENCY. EXCISION OF IPG PERFORMED ON (B)(6) 2009. PRE-OP AND POST-OP DIAGNOSIS: INFECTED IPG. REMOVAL OF SACRAL LEADS PERFORMED ON (B)(6)2009. PRE-OP AND POST-OP DIAGNOSIS: URGENCY, FREQUENCY. EXCISION OF VAGINAL MESH, EXCISION OF SEBACEOUS CYST, SKIN BIOPSY OF AN AREA OF WARTY EXCRESCENCE. PERFORMED ON (B)(6) 2015. PRE-OP DIAGNOSIS: ERODED VAGINAL MESH, SEBACEOUS CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782800 UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC FTL BALLYMONEY - USS UNKNOWN IVS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R