BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2800380 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06786
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED BACK, RECTUM AND BLADDER PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED SCIATICA/BACK PAIN, URGENCY, FREQUENCY , BLADDER PAIN, RECTAL PAIN, ANAL PAIN, CONTINUING DIARRHEA, ATROPHY, URINARY INCONTINENCE, PAIN IN PELVIS, NOCTURIA, URGE FREQUENCY AND LEAKAGE OF URINE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2008, CONCURRENTLY WITH AN APOGEE VAULT SUSPENSION, MONARC SLING PROCEDURE, AND CYSTOSCOPY IN ORDER TO TREAT VAGINAL VAULT PROLAPSE AND VAGINAL PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, MICRO HEMATURIA, URINARY FREQUENCY AND NOCTURIA. (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. 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

    DETAILS: IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, MICRO HEMATURIA, URINARY FREQUENCY AND NOCTURIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH AND MONARC SLING WERE USED. 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3120328

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention MONARC SLING