BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1810032 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00912
    Event Type
    Injury
    Date Received
    August 12, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    SENT TO THE FDA. (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

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERSTIM NEUROSTIMULATOR AND ELECTRODE REMOVAL AND PLACEMENT OF INTERSTIM I AND II ON (B)(6) 2012 DUE TO URGENCY, FREQUENCY AND LEFT HIP PAIN WITH PRIOR INTERSTIM PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. FOLLOW-UP 04 WAS INITIALLY SUBMITTED VIA PAPER MEDWATCH AND MAILED TO THE FDA VIA CERTIFIED (B)(6) ON 9/21/2015. THIS INFORMATION IS BEING RESUBMITTED EMDR AS IT IS UNKNOWN IF THE INFORMATION REACHED THE FDA DATABASE. THE INITIAL MEDWATCH AND SUPPLEMENTAL MEDWATCH REPORTS WERE SENT TO THE FDA VIA USPS. THIS SUPPLEMENTAL MEDWATCH REPORT IS BEING SUBMITTED ELECTRONICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE ON (B)(6) 2008. THE PT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFO WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DURING A PROCEDURE ON (B)(6) 2008, THE SLING WAS IMPLANTED AND PELVIC FLOOR REPAIR MESH WAS EXCISED. ON (B)(6) 2009, THE PATIENT HAD STIMULATION SYSTEM IMPLANT (MEDTRONIC) SURGERY TO TREAT URINARY URGENCY, URINARY FREQUENCY AND NOCTURIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERSTIM NEUROSTIMULATOR AND ELECTRODE REMOVAL AND PLACEMENT OF INTERSTIM I AND II ON (B)(6) 2012 DUE TO URGENCY, FREQUENCY AND LEFT HIP PAIN WITH PRIOR INTERSTIM PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3127594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention