BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3123807 · Received May 22, 2013

    Report

    Report Number
    2210968-2013-05738
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, UTERINE PROLAPSED, RECTOCELE AND CYSTOCELE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD CONCURRENT PROCEDURES OF A LAPAROSCOPIC- ASSISTED VAGINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, MCCALL CULDOPLASTY, POSTERIOR COLPORRHAPHY WITH PERINEOPLASTY AND DIAGNOSTIC CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, SEVERE PAIN DURING INTERCOURSE, URINARY INCONTINENCE, RETENTION AND LEAKAGE, ABNORMAL BOWEL MOVEMENTS, RECTAL PAIN, URINARY AND VAGINAL INFECTIONS, ABNORMAL VAGINAL DISCHARGE WITH ODOR, MESH EROSION BLOCKING URETHRA, SEVERE LOW BACK PAIN, DISCOMFORT WHEN SITTING AND STANDING FOR A LENGTH OF TIME, AND PHYSICAL PAIN AND DISCOMFORT. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL OF MESH ON (B)(6) 2011 DUE TO PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, NOCTURIA, URINARY TRACT INFECTION, BLADDER NECK OBSTRUCTION, VAGINITIS, VULVOVAGINITIS AND DYSPAREUNIA. (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. 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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND UTEROVAGINAL PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF LAVH, LSO, MCCALL¿S CULDOPLASTY, POSTERIOR COLPORRHAPHY WITH PERINEOPLASTY AND CYSTOSCOPY DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF VAGINAL MESH DUE TO MESH EROSION ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(64) 2010 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
    225917 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3346203

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention