BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2880266 · Received December 19, 2012

    Report

    Report Number
    2210968-2012-08123
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR/POSTERIOR REPAIR DUE TO STRESS URINARY INCONTINENCE, RECTOCELE AND CYSTOCELE. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. IT WAS REPORTED THAT THE PATIENT HAD HEMORRHAGING REPAIRED TORN SUTURES ON (B)(6) 2005. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH INCISION ON (B)(6) 2012 FOR VOIDING DYSFUNCTION. DUE TO PAIN, EROSION, EXTRUSION, INFECTIONS AND URINARY PROBLEMS, THE PATIENT UNDERWENT A SLING EXCISION ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, DYSURIA, URGENCY AND HEMATURIA.(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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL SCARRING, RECURRENT STRESS URINARY INCONTINENCE AND URINARY FREQUENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCOMPLETE BLADDER EMPTYING, NOCTURIA, URINARY HESITANCY AND STRAINING.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE, RECTOCELE AND A SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT AN ANTERIOR/POSTERIOR REPAIR. DUE TO PAIN, EROSION, EXTRUSION, INFECTIONS AND URINARY PROBLEMS, THE PATIENT UNDERWENT A SLING EXCISION ON (B)(6) 2012. (B)(4) - URINARY PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1132063

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention