BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1020683 · Received March 28, 2008

    Report

    Report Number
    2210968-2008-00207
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    November 11, 2007
    Report Date
    February 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/27/2008. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN 2007. IMMEDIATELY FOLLOWING THE SURGERY, THE PT DEVELOPED CONTINUOUS RIGHT-SIDED INGUINAL PAIN THAT INCREASED WITH ACTIVITY. THE PT SAW HER FAMILY PHYSICIAN DURING 2008, WHO SUSPECTED AN INGUINAL HERNIA AND REFERRED HER TO A GENERAL SURGEON. THE PT SAW THE GENERAL SURGEON DURING THE FOLLOWING MONTH, WHO ADVISED A CAT SCAN. THE CAT SCAN WAS REPORTEDLY NEGATIVE AND HE PRESCRIBED IBUPROFEN AND GABAPENTIN 300MG THREE TIMES PER DAY. THE CUSTOMER DISCONTINUED BOTH MEDICATIONS AS THE IBUPROFEN UPSET HER STOMACH AND THE GABAPENTIN DID NOT RESOLVE THE PAIN. CURRENTLY, THE PT IS TAKING EXTRA STRENGTH TYLENOL FOR PAIN AND HAS AN APPOINTMENT THE NEXT MONTH WITH A GYNECOLOGIST FOR FURTHER EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention