BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3230996 · Received July 17, 2013

    Report

    Report Number
    2210968-2013-13482
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    August 24, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT URETHROLYSIS AND ANTERIOR/POSTERIOR REPAIR WITH MESH ON (B)(6) 2012 DUE TO CYSTOCELE AND VOIDING DYSFUNCTION. IT WAS REPORTED THAT PATIENT UNDERWENT URETHRAL LYSIS, CYSTOCELE REPAIR WITH REPLIFORM AND EXCISION OF SUPRAPUBIC MASS ON (B)(6) 2012 DUE TO VOIDING DYSFUNCTION, OBSTRUCTION AND CYSTOCELE. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/17/2013. ADDITIONAL INFORMATION: IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO POP, SUI, CYSTOCELE, AND RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL MESH REMOVAL DUE TO MESH MIGRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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) 2009 AND MESH AND AMS SPARC WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT 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
    331783 GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3233128

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention AMS SPARC.| AMS SPARC