BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3170669 · Received June 14, 2013

    Report

    Report Number
    2210968-2013-07306
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-07304. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, ORGAN PERFORATION, AND RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2013 DUE TO FREQUENCY, URGE, URINARY, AND STRESS INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-07304. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 5/17/2016. ADDITIONAL INFORMATION: AGE AT TIME OF EVENT, DATE OF BIRTH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED CONCURRENTLY WITH POSTERIOR REPAIR. IT WAS REPORTED THAT THE PATIENT UNDERWENT COMPLETE INTERSTIM IMPLANTATION WITH INCISION AND IMPLANTATION OF TINED QUADRIPOLAR LEAD ELECTRODES INTO FORAMEN S3, SUBCUTANEOUS IMPLANTATION OF SACRAL NERVE NEUROSTIMULATOR , ELECTRONIC ANALYSIS AND COMPLEX PROGRAMMING, AND FLUOROSCOPIC GUIDANCE FOR NEEDLE PLACEMENT ON (B)(6) 2013 DUE TO URGE INCONTINENCE, SUI AND FREQUENCY; INCISION AND DRAINAGE, IRRIGATION AND DRAINAGE OF WOUND ON (B)(6) 2013 DUE TO WOUND INFECTION OF IMPLANTABLE INTERSTIM; AND REMOVAL OF INTERSTIM GENERATOR WITH THE S3 PERMANENT LEAD FROM THE RIGHT SIDE AND REMOVAL OF SUBCUTANEOUS FISTULA ON (B)(6) 2013 DUE TO CHRONIC INFECTED INTERSTIM SITE AND SUBCUTANEOUS FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(64.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STAGE 3 VAGINAL VAULT PROLAPSE.NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS 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
    271707 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1382690

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention