BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2242042 · Received September 9, 2011

    Report

    Report Number
    2210968-2011-01275
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN POST PROCEDURE. THE PHYSICIAN PERFORMED A SONAR TO DETERMINE THE CAUSE OF THE PAIN AND PRESCRIBED MEDICATION. ON (B)(6) 2011, THE PATIENT UNDERWENT REMOVAL OF THE SLING AND THE PAIN DISAPPEARED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention