BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2945861 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00743
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT SYMPTOMATIC PELVIC ORGAN PROLAPSE WITH FECAL INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF CYSTOSCOPY, SACROSPINOUS LIGAMENT VAULT FIXATION AND ANAL SPHINCTER PLICATION PERFORMED DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN AND BOWEL PROBLEMS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH AND CYSTOSCOPY ON (B)(6) 2013 BY DR. (B)(6) DUE TO INCAPACITATING PELVIC PAIN AFTER INSERTION OF VAGINAL MESH FOR REPAIR OF PELVIC ORGAN PROLAPSE AT THE (B)(6) HOSPITAL AND MEDICAL CENTER, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH AND CYSTOSCOPY ON (B)(6) 2013 BY DR. (B)(6) DUE TO INCAPACITATING PELVIC PAIN AFTER INSERTION OF VAGINAL MESH FOR REPAIR OF PELVIC ORGAN PROLAPSE AT THE (B)(6) HOSPITAL AND MEDICAL CENTER, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
    50598 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NA 2990245

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention