BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3170264 · Received June 14, 2013

    Report

    Report Number
    2210968-2013-07292
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2010 IN ORDER TO TREAT PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE, AND RECTOCELE CONCURRENTLY WITH AMS ELEVATE, CYSTOSCOPY, PUBOVAGINAL SLING, RECTAL EXAM, AND RECTOCELE REPAIR WITH SACRAL SPINOUS FIXATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSURETHRAL COAPTITE IMPLANTATION DUE TO FAILED SLING/PERSISTENT STRESS URINARY INCONTINENCE ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCONTINENCE, FREQUENCY, URGENCY, AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND THE AMS ELEVATE WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271625 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. SAN LORENZO NA BJB032

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention AMS ELEVATE