BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2780845 · Received October 10, 2012

    Report

    Report Number
    2210968-2012-06279
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED INFECTION, URINARY DISTURBANCES, BOWEL DISTURBANCE AND VAGINAL SCARRING. (B)(4). THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06280, 2210968-2012-06281, AND 2210968-2013-24425. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO VAGINAL VAULT PROLAPSE, CYSTOCELE, AND RECTOCELE REPAIR. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06280, 2210968-2012-06281, 2210968-2013-24425, AND 2210968-2013-33881. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY HESITANCY, DYSURIA, URINARY FREQUENCY, VAGINAL DISCOMFORT WITH PRESSURE AND URINARY TRACT INFECTION. (B)(4).

    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 THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06280 AND 2210968-2012-06281.THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY HESITANCY, DYSURIA, URINARY FREQUENCY, VAGINAL DISCOMFORT WITH PRESSURE AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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 2989676

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention