BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760497 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05606
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A SUPRACERVICAL HYSTERECTOMY, ABDOMINAL SACRAL COLPOPEXY, AND CYSTOSCOPY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH AND MONARC SLING WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, MULTIPLE PROBLEMS WITH BOWELS AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. DUE TO POSTOPERATIVE BRONCHITIS WITH A LOT OF COUGHING THE PATIENT EXPERIENCED FAILURE OF RECTOCELE REPAIR DURING 2008 IMPLANTATION. THIS EPISODE LED TO A SUPRACERVICAL HYSTERECTOMY AND REPEAT RECTOCELE REPAIR WITH RETROPUBIC SLING WITH SPARC ON (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURES ON (B)(6) 2009 AND (B)(6) 2008 AND PELVIC FLOOR REPAIR MESH, A SPARC, A MONARC SLING AND INTERPOL LLP Y-SLINGS WERE IMPLANTED INTO THE PATIENT. THE DATES OF IMPLANTATION FOR THE SPECIFIC PRODUCTS WERE NOT CLARIFIED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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 3095960

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTERPROL LLP| MONARC| MONARC SLING| SPARC| SPARC| INTERPROL LLP| MONARC SLING| MONARC