BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 5384098 · Received January 21, 2016

    Report

    Report Number
    1018233-2012-01069
    Event Type
    Other
    Date Received
    January 21, 2016
    Report Date
    January 11, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED EROSION, EXTRUSION, BLOOD LOSS, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 0

    COMPLAINT # (B)(4). PER ADDITIONAL INFO RECEIVED, THE PATIENT HAS EXPERIENCED "SEVERE ABDOMINAL PAIN" - UNSPECIFIED "COLON PROBLEMS"- "CONTINUED PULLING SENSATION IN LOWER RIGHT ABDOMINAL REGION", "VAGINAL BLEEDING AND DISCHARGE", "ORIGINAL SURGICAL SITE WAS NOT HEALING PROPERLY", "RECURRENT CHRONIC VAGINAL PAIN ASSOCIATED WITH BLADDER INFECTIONS AND PELVIC PAIN", AND "PROLAPSE BLADDER". PER THE PT'S MEDICAL RECORDS, THE PT EXPERIENCED VAGINAL MESH EROSION. THE PT UNDERWENT AN EXCISION OF VAGINAL MESH FOR THE PREOPERATIVE DIAGNOSIS OF VAGINAL MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43114 PELVITEX POLYPROPYLENE MESH FTL SOFRADIM PRODUCTION NA PHG00191

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female Required Intervention ALIGN RS URETHRAL SUPPORT SYSTEM | AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM