BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2982484 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01806
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    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. 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 2210968-2013-01807 AND 2210968-2013-01812 . THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE WITH INTRINSIC SPHINCTER DEFICIENCY, ANTERIOR AND POSTERIOR VAGINAL VAULT PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF AN ANTERIOR AND POSTERIOR REPAIR, AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY FREQUENCY, NOCTURIA, AND INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(4) 2015.

    Additional Manufacturer Narrative · 1

    PATIENT CODE: (B)(4)- RECTOCELE ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF ERODED VAGINAL MESH, POSTERIOR COLPOPERINCORRHAPHY AND CYSTOURETHROSCOPY ON (B)(6) 2011 BY DR.(B)(6), DUE TO SYMPTOMATIC RECTOCELE WITH EROSION OF PREVIOUSLY PLACED POSTERIOR VAGINAL SURGICAL MESH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT CODE: (B)(4) ¿ URINARY TRACT INFECTION ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY FREQUENCY, NOCTURIA, AND INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87600 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3171229

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention