BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2870474 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-08061
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PARAVAGINAL REPAIR AND ANTERIOR COLPORRHAPHY DUE TO CYSTOCELE GRADE 4, RECTOCELE GRADE 1-2 AND VAULT PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, PRESSURE AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT HAD PORTIONS OF MESH REMOVED DURING DOCTOR VISITS. IT IS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2011 DUE TO MESH EROSION, SPOTTING AND DYSPAREUNIA. (B)(6). (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    1 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3270160

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention