BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972660 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01515
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND INCISIONAL SEPARATION REPAIR FOR THE MESH ON (B)(6) 2007.

    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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF CYSTOSCOPY, AND ANTERIOR/POSTERIOR COLPORRHAPHY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2007. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECTOCELE REPAIR ON (B)(6) 2009. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DIFFICULTY EMPTYING HER BLADDER, RECURRENT URINARY INCONTINENCE AND URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL (B)(4) NARRATIVE: IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT EXCISION OF SCARRING AT THE VAGINAL CUFF, AND LAPAROSCOPIC EXAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    76169 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2963392

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention