BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3201153 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11861
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT CYSTOSCOPY, RIGHT URETEROSCOPY AND LASER LITHOTRIPSY WITH RIGHT URETERAL STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL SCAR AND MESH RESECTION AND REVISION ON (B)(6) 2013 DUE TO VAGINAL PAIN AND EXCESS SCARRING. IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT CYSTOSCOPY LEFT URETEROSCOPY, HOLIUM LASER LITHOTRIPSY, LEFT URETERAL STONE EXTRACTION AND LEFT URETERAL STENT PLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, PELVIC FLOOR RECONSTRUCTION AND PERITONEAL BIOPSY DUE TO SUI, CHRONIC PAIN AND RECTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT A MESH REVISION AND REMOVAL ON (B)(6) 2009 AND (B)(6) 2013. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).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 SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND 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
    303382 GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2893626

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention