BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2924665 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00496
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, PERINEOPLASTY, LYSIS OF ADHESIONS, ABDOMINAL SACROCOLPOPEXY, ENTEROCELE REPAIR, RECTOCELE REPAIR, AND CYSTOCELE REPAIR, DUE TO STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, RECTAL PROLAPSE, CYSTOCELE, AND GAPING INTROITUS. THE PATIENT UNDERWENT PERINEOPLASTY ON (B)(6) 2009.

    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. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00495, MEDWATCH 2210968-2013-00497 AND MEDWATCH 2210968-2013-00498. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS EXPLANTED ON (B)(6) 2007 DUE TO VAGINAL PROLAPSE AND ON (B)(6) 2009 DUE TO RECURRENCE OF PROLAPSE , INCONTINENCE AND LYSIS OF ADHESIONS. (B)(4) ¿PROLAPSE. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00495, MEDWATCH 2210968-2013-00497 AND MEDWATCH 2210968-2013-00498. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT HAD A PERIGEE AND MONARC HAMMOCK IMPLANTED ON (B)(6) 2009. 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
    29592 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA XCP064

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention