BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2772316 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06089
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT SILVER NITRATE APPLICATION TO MILDLY FRIABLE TISSUE SURROUNDING MESH ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT UNDERWENT SILVER NITRATE APPLICATION TO MESH EROSION ON (B)(6) 2010.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06090. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TWO ON-Q TROCAR INSERTION AND CATHETER PLACEMENT; DUE TO POP. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, MESH EROSION, VAGINAL SCARRING, VAGINAL BLEEDING, DYSPAREUNIA, EXTRUSION, INFECTION, RECURRENCE AND EMOTIONAL DISTRESS. IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT WITH SILVER NITRATE FOR MESH COMPLICATIONS AND SECOND VAGINAL RECONSTRUCTIVE SURGERY ON 07/11/2011 FOR REMOVAL OF ERODED POSTERIOR MESH AND RELEASE OF THE MESH BANDS IN THE ANTERIOR COMPARTMENT. IT WAS REPORTED THAT THE PATIENT ALSO UNDERWENT MESH REVISION ON 01/19/2007 FOR MESH EROSION, PAIN, BLEEDING AND INFECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-06090 AND 2210968-2014-14978. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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 WAS USED. 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1358098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention