BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2032012 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00364
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URINARY TRACT INFECTION. 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

    (B)(4): IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN (B)(6) 2010. THE PATIENT HAD PROBLEMS PASSING URINE AFTER THE PROCEDURE AND WAS SENT HOME AND WAS ILL AT HOME. ON (B)(6) 2010, THE PATIENT DID NOT FEEL WELL AND WAS TOLD TO DRINK MORE WATER. THE DAUGHTER TOOK THE PATIENT BACK TO THE HOSPITAL ON (B)(6) 2010 BECAUSE THE PATIENT HAD NAUSEA, PAIN AND A HIGH TEMPERATURE. IT WAS FOUND THAT THE PADDING IN THE VAGINA HAD BEEN LEFT IN PLACE, AND WAS NOT REMOVED AFTER THE PROCEDURE. THE PATIENT DEVELOPED A URINARY TRACT INFECTION A FEW WEEK AFTER THE PROCEDURE AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS STILL EXPERIENCING LEAKING OF URINE OCCASIONALLY, PLUS SENSATION THAT SHE HAS NOT VOIDED COMPLETELY. THE PATIENT'S LEAKING OF URINE WAS WORSE THAN BEFORE THE SURGERY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010. THE PATIENT HAD PROBLEMS PASSING URINE AFTER THE PROCEDURE AND WAS SENT HOME AND WAS ILL AT HOME. THE DAUGHTER TOOK THE PATIENT BACK TO THE HOSPITAL AND IT WAS FOUND THAT THE PADDING IN THE VAGINA HAD BEEN LEFT IN PLACE, AND WAS NOT REMOVED AFTER THE PROCEDURE. THE PATIENT WAS ALSO TREATED FOR URINARY TRACT INFECTION WITH ANTIBIOTICS. THE PATIENT WAS STILL EXPERIENCING LEAKING OF URINE OCCASIONALLY, PLUS SENSATION THAT SHE HAS NOT VOIDED COMPLETELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention