BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2964021 · Received February 15, 2013

    Report

    Report Number
    2210968-2013-01226
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT PATIENT UNDERWENT A MESH REVISION ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL HYSTERECTOMY / BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS AND CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE AND MENORRHAGIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF POSTERIOR VAGINAL WALL MESH EXTRUSION WITH PRIMARY REPAIR UTILIZING A PERITONEAL FLAP ON (B)(6) 2011 DUE TO POSTERIOR VAGINAL WALL MESH EXTRUSION.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND RIGHT SALPINGO- OOPHORECTOMY DUE TO MENORRHAGIA, RIGHT OVARIAN CYST, AND RECTOCELE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH AND COLOPLAST ARIS MESH WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    67162 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3157283

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention