BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760485 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05677
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (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 MESH IMPLANTATION TO TREAT CYSTOCELE AND RECTOCELE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ADHESIONS, URINARY INCONTINENCE AND URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT PELVIC INFECTIONS, VAGINAL INFECTIONS, AND URINARY TRACT INFECTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL MESH KIT REMOVAL, URETHROLYSIS, ENTEROCELE REPAIR, POSTERIOR COLPORRHAPHY AND DIAGNOSTIC CYSTOSCOPY ON (B)(6) 2017 BY DR. (B)(6), MD DUE TO MESH KIT IMPLANT COMPLICATION: DYSPAREUNIA; CHRONIC PELVIC PAIN; MESH KIT EXPOSURE IN THE ANTERIOR VAGINAL WALL AND POSTERIOR VAGINAL WALL WITH SIGNIFICANT SURROUNDING TISSUE CONTRACTION AND TISSUE FIBROSIS.

    Additional Manufacturer Narrative · 1

    (B)(4) - EXPOSURE. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING IMPLANTATION, THE PATIENT HAS EXPERIENCED FREQUENT INFECTIONS AND PAIN IN HER PELVIS, BLADDER AND RECTUM. SHE WAS TREATED WITH CIPRO AND FLAGYL DUE TO CHRONIC PELVIC INFLAMMATORY DISEASE SECONDARY TO EXPOSED MESH AND INFECTION ON (B)(6) 2011. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD EXPOSED ANTERIOR AND POSTERIOR MESH. HER INFECTION IMPROVED WITH ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT PELVIC INFECTIONS, VAGINAL INFECTIONS, AND URINARY TRACT INFECTIONS.

    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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3289034

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention