BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2780795 · Received October 10, 2012

    Report

    Report Number
    2210968-2012-06349
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/13/2015. (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2012, DUE TO CHRONIC LEFT SIDED PAIN, AND EXPOSED MESH. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REPAIR OF RECURRENT VENTRAL HERNIA AND LYSIS OF ADHESIONS ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT CHOLECYSTECTOMY WITH CHOLELITHIASIS ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH AND SUTURE REMOVAL ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REPAIR OF RECURRENT VENTRAL HERNIA AND LYSIS OF ADHESIONS ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2013, DUE TO VAGINAL VAULT PROLAPSE AFTER HYSTERECTOMY, VAGINAL PAIN, AND VAGINAL MESH EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2014, DUE TO RECURRENT INCARCERATED INCISIONAL HERNIA WITH LARGE BOWEL IN THE HERNIA, LEFT UPPER QUADRANT PORT SITE INCISIONAL HERNIA, AND REDUNDANT COMPROMISED ABDOMINAL WALL TISSUE WITH PANNUS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF NECROTIC TISSUE ON (B)(6) 2014, DUE TO BLEEDING, LOWER ABDOMINAL PAIN, AND A KNOT ON LEFT SIDE OF ABDOMEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 05/05//2016. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENT UTI, BACTERIAL VAGINOSIS, VAGINAL DISCHARGE AND VAGINAL ITCHING, CHRONIC CYSTITIS, URINARY HESITANCY AND INCOMPLETE BLADDER EMPTYING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 TO TREAT PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE AND AN OBTURATOR SLING WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES: ON (B)(6) 2009, (B)(6) 2010 AND (B)(6) 2011 MESH REVISION DUE TO VAGINAL PAIN AND INFECTION; ON (B)(6) 2010 HYSTERECTOMY AND MESH REVISION, ON (B)(6) 2010 BOWEL HERNIA REPAIR; ON (B)(6) 2011 MESH REVISION AND ANTERIOR PROLAPSED REPAIR, ON (B)(6) 2011 MESH EXPLANT AND POSTERIOR PROLAPSED REPAIR. (B)(4). 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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06350 AND 2210968-2012-06351. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3270025

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention