BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOLE PRODUCT

    MDR report key: 2930437 · Received December 18, 2012

    Report

    Report Number
    9617613-2012-00277
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    August 3, 2006
    Report Date
    October 5, 2018
    Manufacturer
    COVIDIENT, FORMERLY TISSUE
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: DATE OF REPORT: (B)(6) 2012, BRAND NAME: PELVICOL ACELLULAR COLLAGEN MATRIX, MANUFACTURER: (B)(4), (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: 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 PAINFUL INTERCOURSE, MESH EROSION, AND CONTINUED STRESS INCONTINENCE. VAGINAL MESH EROSION REQUIRING EXCISION SURGERY, ACUTE CYSTITIS, DYSPAREUNIA, DYSURIA, URINARY TRACT INFECTIONS, URINARY FREQUENCY AND URGENCY, NOCTURIA, BLADDER SPASMS, PELVIC, VAGINAL AND GROIN PAIN RADIATING DOWN LEFT LEG, RECURRENT STRESS INCONTINENCE, URGE INCONTINENCE, YEAST INFECTION, VAGINAL ODIFEROUS DISCHARGE, HEMATURIA, URINARY HESITATION AND INCOMPLETE BLADDER EMPTYING, THINNING OF RIGHT PUBORECTALIS MUSCLE WITH FECAL URGENCY AND INCONTINENCE, SMALL CYSTOCELE, URETHRAL HYPERMOBILITY, ANTERIOR RECTOCELE, URINARY DYSFUNCTION, DEPRESSION, AND ANXIETY. ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM - IMPLANT (B)(6) 2010. GORE - TEX MONARCH TAPE WAS REPORTED TO BE USED/IMPLANTED DURING THE SAME PROCEDURE. IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT ASA RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAINFUL INTERCOURSE, MESH, EROSION, AND CONTINUED STRESS INCONTINENCE. ASSOCIATED MDRS: 1018233-2012-00342.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention| O GORE - TEX MONARCH TAPE| IMPLANT DATE:| GORE - TEX MONARCH TAPE| IMPLANT DATE: