BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2771827 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06023
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 20, 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT SPARC SLING IMPLANTATION ON (B)(6) 2004. ON (B)(6) 2008, THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED WITH A CONCURRENT SURGICAL PROCEDURE OF A PARTIAL HYSTERECTOMY. ALSO ON (B)(6) 2008, SPARC SLING WAS REMOVED. IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING BLADDER INFECTIONS, INCREASE IN URINARY INCONTINENCE AND DYSPAREUNIA IN 2008. (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND (B)(6) 2008 AND MESH AND SPARC WERE USED. IT WAS NOT STATED WHICH PRODUCT WAS USED ON WHICH DATE. 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 3158815

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SPARC| SPARC