BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 2975501 · Received February 12, 2013

    Report

    Report Number
    9617613-2013-00017
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    February 18, 2009
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PERSISTENT VAGINAL MESH EROSIONS REQUIRING 4 EXCISION SURGERIES, FOREIGN BODY REACTION TO PELVICOL GRAFT, VAGINAL ETHIBOND SUTURE EROSION, BURNING SENSATION IN THE PERINEUM, SUTURE REMOVAL, LEVATOR MUSCLE TENDERNESS, CONSTIPATION, GRANULATION TISSUE REQUIRING TRIMMING/EXCISIONS, DYSPAREUNIA REQUIRING PHYSICAL THERAPY, VAGINAL SPOTTING AFTER INTERCOURSE, BLADDER CRAMPING PELVIC PAIN REQUIRING EXCISION OF MESH, VAGINAL BLEEDING, PELVIC CRAMPING, PRURITUS AT VAGINAL INTROITUS, LEFT LEVITATOR SPASM REQUIRING TRIGGER POINT INJECTIONS, URINARY URGENCY/FREQUENCY AND EXTREME ANXIETY. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ASSOCIATED MDRS: 1018233-2012-01167, 1018233-2012-01181, AND 101/233-2013-00092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62137 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| O