BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2113083 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00708
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K13718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE FOR A UTERINE PROLAPSE ON (B)(6) 2010 AND AN UNKNOWN PRODUCT WAS USED. THE UNKNOWN PRODUCT USED IN THE PROCEDURE BECAME LOOSE ACCORDING TO THE REPORTER, WHO WAS THE SON OF THE PATIENT. THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2010 AND PELVIC FLOOR REPAIR MESH WAS USED. FOLLOWING THIS PROCEDURE, THE PATIENT EXPERIENCED PAIN, SWELLING, INABILITY TO WALK FAST, DIFFICULTY SITTING, AND DISCOMFORT TO SLEEP. THE PATIENT WAS EVALUATED BY THE PHYSICIAN WHO THOUGHT THERE WAS AN EXCESS OF PRODUCT IN HER BODY AND WHICH WAS CAUSING A REJECTION. THE MESH HAS NOT BEEN REMOVED. THE PATIENT IS RESTING AND TAKING ANALGESICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON NA 3374662

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention