BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3053208 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03741
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013. (B)(4). 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

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY DUE TO VAGINAL VAULT PROLAPSE, CYSTOCELE AND RECTOCELE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, AND OBSTRUCTION. THE PATIENT UNDERWENT REMOVAL OF DISTAL PORTION OF MESH ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2007. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED NOCTURIA, HESITANCY, URINARY FREQUENCY, INCOMPLETE BLADDER EMPTYING, DIFFICULTY INITIATING URINATION, RECURRENT URINARY TRACT INFECTIONS, GRANULATION TISSUE, VAGINAL SCARRING, PERSISTENT THROBBING, PELVIC PAIN, AND POOR URINE STREAM. IT WAS REPORTED THAT PATIENT HAD TO STAND, BEND FORWARD AND CHANGE POSITIONS IN ORDER TO URINATE. IN ADDITION, THE PATIENT EXPERIENCED YEAST INFECTIONS, HEMORRHOIDS, RECTAL ISSUES, WORSENING URINARY INCONTINENCE, URETHRAL PROLAPSE, VAGINAL BURNING, ITCHING AND PAIN, BLADDER SPASMS REQUIRING PAIN MEDICATION TO RELAX BLADDER, DYSPAREUNIA, VAGINAL BLEEDING, SIGNIFICANT TTP WITH BUNCHING OF APICAL PORTION MESH, DYSURIA, PERSISTENT VAGINAL PAIN, AND SYMPTOMS OF IRRITATION. IT WAS REPORTED THAT THE PATIENT GOT UP 3-8 TIMES A NIGHT AND DIFFICULTY EMPTYING BLADDER AFFECTING SLEEPING PATTERNS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155322 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3029810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention