BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2840411 · Received July 13, 2012

    Report

    Report Number
    9617613-2012-00080
    Event Type
    Injury
    Date Received
    July 13, 2012
    Date of Event
    November 2, 2010
    Report Date
    June 26, 2018
    Manufacturer
    COVIDIENT, FORMERLY TISSUE...
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADDITIONAL INFO FROM IMPORTER REPORT: IT WAS REPORTED IN THE PT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED CHRONIC PAIN, SMALL GRAFT DEHISCENCE POSTERIOR VAGINAL WALL, RECURRENT VAGINAL STENOSIS REQUIRING PELVIC FLOOR PHYSICAL THERAPY, SMALL BOWEL OBSTRUCTION, MIXED URINARY INCONTINENCE, VOIDING DYSFUNCTION, LEVATOR SPASM STATUS POST MULTIPLE OPERATIONS FOR POSTERIOR VAGINAL WALL MESH EROSIONS, VAGINAL SCARRING/ADHESIONS, RECTAL BLEEDING, ABDOMINAL HERNIA REPAIR WITH LYSIS OF ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PRODUCT PELVICOL PRODUCT FTL COVIDIENT, FORMERLY TISSUE... NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention| O