BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2923839 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00455
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED PAIN, BLEEDING, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND URINARY/BOWEL PROBLEMS. PATIENT UNDERWENT MESH REVISION DUE TO PAIN ON (B)(6) 2012. (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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT VAGINAL VAULT PROLAPSE, RECTOCELE, DEEP DYSPAREUNIA, AND POINT PAIN TO TOUCH OF THE RIGHT DISTAL UTEROSACRAL LIGAMENT INSERTION INTO THE VAGINA, AND MESH WAS IMPLANTED. AT THE TIME OF INSERTION IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF POSTERIOR COLPORRHAPHY, VAGINAL COLPOPEXY WITH BILATERAL SACROSPINOUS FIXATION, AND RESECTION OF RIGHT DISTAL UTEROSACRAL LIGAMENT. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 TO INSERT AN ADJUSTABLE MID URETHRAL SLING FOR STRESS URINARY INCONTINENCE AND REPAIR.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 01/27/2017. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTREME PAIN AND WAS UNABLE TO HAVE INTERCOURSE, DIFFICULT TIME VOIDING, VOIDS INTERMITTENTLY, DOES NOT EMPTY ADEQUATELY, AND HAD TWO BLADDER INFECTIONS, URINARY HESITANCY, BOWEL INCONTINENCE, DIARRHEA AND CONSTIPATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH EXCISION, EXCISION OF ABDOMINAL DEVICE, DIAGNOSTIC CYSTOSCOPY AND PROCTOSCOPY WITH ANOSCOPY ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31018 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3256761

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention