BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2792430 · Received October 16, 2012

    Report

    Report Number
    2210968-2012-06567
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY AND CULDOPLASTY; DUE TO ANTERIOR APICAL POSTERIOR PELVIC RELAXATION AND SUI. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL MESH, CYSTOSCOPY, HYSTEROSCOPY AND D&C ON (B)(6) 2008 DUE TO VAGINAL MESH EXTRUSION AND POSTMENOPAUSAL BLEEDING.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH AND MONARC SUBFASCIAL HAMMOCK WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTO ETHICON INC NA 3030491

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention MONARC SUBFASCIAL HAMMOC