BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2945816 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00875
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENSION ON (B)(6) 2011, DUAL TINE LEAD PLACEMENT OF INTERSTIM STAGE 1 ON (B)(6) 2007, REMOVAL OF IPG AND TINE LEADS ON (B)(6) 2008 AND PLACEMENT OF INTERSTIM 2 ON (B)(6) 2007. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 FOR EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. 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). 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 AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00874. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL MESH REVISION AND INJECTION OF BOTOX INTO LEVATOR ANI MUSCLES BILATERALLY ON (B)(6) 2013. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF INTERSTIM LEAD FROM BACK AND PELVIC FLOOR TRIGGER POINT INJECTION WITH BOTOX ON (B)(6) 2013. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4) TREATMENT WITH MEDICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED DYSPAREUNIA AND INTERSTITIAL CYSTITIS.

    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 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
    49636 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 2921328

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention