BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2646520 · Received July 9, 2012

    Report

    Report Number
    2210968-2012-02649
    Event Type
    Injury
    Date Received
    July 9, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAP. EXAM, LSO, LYSIS OF ADHESIONS, AND REMOVAL OF LESION FROM LEFT LATERAL WALL OF PELVIS, PROBABLE ENDOMETRIOSIS, ON (B)(6) 2009 DUE TO PELVIC PAIN, UNRESPONSIVE TO MEDICAL TREATMENT, AND MULTIPLE CYSTS ON LEFT OVARY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    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): IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT FIBROIDS, DYSPAREUNIA, STRESS URINARY INCONTINENCE AND MENORRHAGIA. THE PATIENT CONCURRENTLY HAD A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THAT AFTER IMPLANTATION PATIENT EXPERIENCED PAIN, INFECTION, DYSPAREUNIA, VAGINAL SCARRING, URINARY/BOWEL PROBLEMS AND BACK ACHES.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2006. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2904050

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention