BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2920990 · Received January 17, 2013

    Report

    Report Number
    2210968-2013-00416
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 BY DR. (B)(6), DUE TO RETAINED FOREIGN BODY IN THE BLADDER - REMNANT OF TVT SLING AND LYSIS OF RETROPUBIC BLADDER ADHESIONS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF THE VAGINAL RETAINED FOREIGN BODY AND CYSTOSCOPY ON (B)(6) 2009 BY (B)(6) FOR RETAINED FOREIGN BODY IN THE VAGINA AND URGENCY. IT WAS REPORTED THAT PATIENT UNDERWENT CONCURRENT CYSTOSCOPY AND EXCISION OF PUBOVAGINAL SLING PROCEDURES.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND REMOVAL OF SLING ON (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A SLING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 BY DR. (B)(6), DUE TO RETAINED FOREIGN BODY IN THE BLADDER - REMNANT OF TVT SLING AND LYSIS OF RETROPUBIC BLADDER ADHESIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF THE VAGINAL RETAINED FOREIGN BODY AND CYSTOSCOPY ON (B)(6) 2009 BY (B)(6) FOR RETAINED FOREIGN BODY IN THE VAGINA AND URGENCY. IT WAS REPORTED THAT PATIENT UNDERWENT CONCURRENT CYSTOSCOPY AND EXCISION OF PUBOVAGINAL SLING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25978 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC NA 3157220

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention