BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3073535 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04338
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 - (B)(6) 2012 DUE TO PAIN AND DYSPAREUNIA.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04339 AND MEDWATCH 2210968-2012-04337. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SUI AND POP. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RIGHT INGUINAL HERNIA ON (B)(6) 2007 DUE TO RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF POLYPROPYLENE VAGINAL MESH AT THE ANTERIOR CERVICAL PORTIO AND ANTERIOR VAGINAL EPITHELIUM AND CYSTOSCOPY ON (B)(6) 2009 DUE TO EXPOSURE OF VAGINAL MESH WITH VAGINAL DISCHARGE AND BLEEDING. IT WAS REPORTED THAT THE PATIENT UNDERWENT COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2012 DUE TO 0.8 CM POLYP, SEMI-PEDUNCULATED, REMOVED WITH CAUTERY SIGMOID COLON, DIVERTICULOSIS SIGMOID MILD, SMALL INTERNAL HEMORRHOIDS AND MILD MELANOSIS COLI. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    173344 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 2935078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention