BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3211395 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12428
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 18, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASON FOR SURGERY: 2ND DEGREE RECTOCELE, AND 3RD DEGREE CYSTOCELE. CONCURRENT PROCEDURES: VAGINAL PARAVAGINAL ANTERIOR REPAIR, POSTERIOR COLPORRHAPHY, AND CYSTOSCOPY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH ON (B)(6) 2009 ALONG WITH REVISION OF ANTERIOR & POSTERIOR REPAIR DUE TO MESH EROSION AND DYSPAREUNIA. THE PATIENT UNDERWENT CHOLECYSTECTOMY IN 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT TRIMMING OF MESH SUTURES ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT TRIMMING OF MESH ON (B)(6) 2012. (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.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 08/10/2016.

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. THE PATIENT 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
    309288 GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3263758

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention