BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2961505 · Received February 14, 2013

    Report

    Report Number
    2210968-2013-01083
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    (B)(4): IT WAS REPORTED THAT THE PATIENT FIRST EXPERIENCED SYMPTOMS OF MESH EROSION ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2009. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2012 AND A VAGINAL MESH EROSION WAS NOTED. THE MESH EROSION WAS MIDLINE. THE PATIENT EXPERIENCED PAIN DURING INTERCOURSE. THE PATIENT UNDERWENT A PROCEDURE FOR CLOSURE ON (B)(6) 2012. THE PATIENT WAS SEEN BY THE PHYSICIAN FOR FOLLOW-UP ON (B)(6) 2012 AND THE EROSION WAS STILL PRESENT. THE PATIENT HAS BEEN SCHEDULED FOR PROLAPSE SURGERY AND REPEAT CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66093 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3195505

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention