BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2850654 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07568
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. IN ADDITION, 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY AND ABDOMINAL SACROCOLPOPEXY DUE TO RECTOCELE AND CYSTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANTATION OF T-MESH & CYSTOSCOPY SECONDARY TO STRESS URINARY INCONTINENCE, FREQUENCY & URGENCY ON (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT POST INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, FISTULAE, BLEEDING, DYSPAREUNIA AND BOWEL PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2005 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA TGB288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention