BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2771961 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05971
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THE THAT PATIENT UNDERWENT EXAM UNDER ANESTHESIA, CYSTOSCOPY, LEFT URETHRAL STENT PLACEMENT AND SUBSEQUENT LEFT URETHRAL STENT REMOVAL , EXCISION OF ERODED BLADDER MESH AND CYSTOTOMY REPAIR (B)(6) 2013 DUE TO EROSION OF THE RETROPUBIC SUBURETHRAL SLING MATERIAL INTO THE BLADDER WITH COMMON BLADDER STONE FORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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

    IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT ANTERIOR AND POSTERIOR COLPORRHAPHY, SACROSPINOUS LIGAMENT FIXATION, TENSION FREE VAGINAL TAPE, CYSTOSCOPY, BARTHOLINS CYST MARSUPIALIZATION DUE TO STRESS URINARY INCONTINENCE, VAGINAL VAULT PROLAPSED, AND BARTHOLIN CYST.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2004 IN ORDER TO TREAT INCONTINENCE AND PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THE PATIENT UNDERWENT STITCH REMOVAL FROM MESH IMPLANTATION ON (B)(6) 2004 AND PARTIAL REMOVAL OF MESH AND STONES IN BLADDER ON (B)(6) 2010 DUE TO STONE ENTANGLED IN MESH. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) - URINARY PROBLEMS; BLADDER STONES; STONE ENTANGLED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT RECTOCELE, CYSTOCELE, VAGINAL VAULT PROLAPSE, BARTHOLIN CYST AND STRESS AND A SLING WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A BLADDER STONE WITH MESH EROSION SURGERY ON (B)(6) 2010

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2004 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING MESH CONTRACTION, PAIN, EROSION, FORMATION OF SCAR TISSUE, INFECTION, ORGAN PERFORATION, FISTULA, DYSPAREUNIA, NERVE DAMAGE, CHRONIC PELVIC PAIN, URINARY & FECAL INCONTINENCE, AND RECURRENT PROLAPSE OF HER ORGANS REQUIRING ADDITIONAL SURGERIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1084360

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention