BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2961516 · Received February 14, 2013

    Report

    Report Number
    2210968-2013-01078
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE MESH WAS IMPLANTED IN (B)(6) 2008. CONCOMITANTLY, THE PATIENT HAD A CYSTOCELE REPAIR. AT THE TIME OF THE INITIAL PROCEDURE, THE PATIENT HAD AN INTERSTIM FOR INTERSTITIAL CYSTITIS IN PLACE. APPROXIMATELY THREE YEARS AGO, THE PATIENT STARTED TO EXPERIENCE ABDOMINAL PAIN. CURRENTLY, THE PATIENT IS IN PAIN. CYSTOSCOPY SHOWED SOME ERYTHEMATOUS PATCHES THAT WERE BIOPSIED. THE MESH MAY HAVE CONTRACTED BELOW THE BLADDER BASE. THE SURGEON PLANS TO RESECT THAT PART OF THE MESH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2008. THE PATIENT EXPERIENCED AN UNKNOWN COMPLICATION POSTOPERATIVELY. THE PHYSICIAN IS CONSIDERING MESH REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65205 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention