BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3212832 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12569
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    September 26, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO POP. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, URINARY AND BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND BLEEDING. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2007 ALONG WITH OPERATIVE LAPAROSCOPY, EXTENSIVE ABDOMINAL ADHESIOLYSIS AND CYSTOTOMY REPAIR DUE TO PELVIC PAIN AND EXPOSURE OF MESH. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT LAPAROSCOPY, EXCISION OF LEFT UPPER QUADRANT ABDOMINAL WALL LIPOMA AND LAPAROSCOPIC LIVER BIOPSY. IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT BIOPSY OF VAGINAL VAULT. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH FROM BLADDER, COLON AND VAGINA IN (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH AND BLADDER STONES ON (B)(6) 13 DUE TO EROSION OF MESH INTO BLADDER. (B)(4).

    Additional Manufacturer Narrative · 1

    IN ADDITION, 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 GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH AND MONNARC 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
    313639 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention