BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1964078 · Received January 11, 2011

    Report

    Report Number
    2210968-2011-00038
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 14, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BLADDER ATONY. PAIN OCCURRED. URINARY RETENTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2010. ON (B)(6) 2010, THE PT CAME BACK TO THE HOSPITAL WITH A LOT OF PAIN IN HER RIGHT LEG. AN MRI SHOWED IRRITATION OF THE ISCHIADICUS. ON THE SAME DAY, THE PT UNDERWENT ANOTHER SURGICAL PROCEDURE TO REMOVE THE RIGHT ARM OF THE MESH. THEN, THE PAIN WAS REDUCED, BUT STILL PRESENT. ALSO, THE PT DEVELOPED URINARY RETENTION WITH BLADDER ATONY. NEUROLOGIC PAIN WAS TREATED WITH AMITRIPTYLINE AND BLADDER ATONY WITH UBRETID. THE PT HAS GONE BACK TO THE PAIN DESK IN THE HOSPITAL A COUPLE OF TIMES. URINATION IS BETTER BUT THE PT STILL SUFFERS FROM BLADDER ATONY WITH INTERMITTENT SELF-CATHETERIZATION. THE PT ALSO GETS PHYSIO TREATMENT WITH A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT AND HAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL POLYMERIC FTL ETHICON, INC. NA 3422151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention