BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT ABBREVO

    MDR report key: 3203114 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11838
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE IN 2013. THE PATIENT EXPERIENCED A SEVERE BLADDER INFECTION SHORTLY AFTER THE PROCEDURE. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED LEG PAIN WHICH HAS PERSISTED AND HAS CAUSED LIMPING FOR EIGHT MONTHS. THE PATIENT WAS TOLD BY HER PHYSICIAN THAT IT IS SCIATICA PAIN, RELATED TO A PINCHED NERVE IN HER BACK. THE PATIENT HAD AN MRI AND WAS SEEN BY A NEUROSURGEON, WHO WILL DO FURTHER NERVE TESTING. THE PATIENT STATED THAT A MRI SHOWED KIDNEY CYSTS BUT NOTHING RELATED TO LEG PAIN. THE PATIENT WAS PRESCRIBED NEURONTIN. THE PATIENT EXPERIENCED INTERMITTENT BLOODY URINE, BUT WAS TOLD BY HER UROLOGIST THAT IT WAS NOT CONCERNING UNLESS THERE WERE BLOOD CLOTS PRESENT. THE PATIENT ALSO EXPERIENCED A VAGINAL RASH AND WAS TOLD BY THE PHYSICIAN IT WAS DERMATITIS. THE PATIENT EXPERIENCED REACTIONS. THE PATIENT LOST CONTROL OF HER BOWELS AND QUESTIONED WHETHER IT MAY HAVE BEEN CAUSED BY EROSION OF THE MESH. THE PATIENT HAS A SLOW STREAM OF URINE BUT INCONTINENCE IS MUCH BETTER. (B)(4).

    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 BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE ON (B)(6) 2012. THE PATIENT EXPERIENCED A SEVERE BLADDER INFECTION SHORTLY AFTER THE PROCEDURE. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED LEG PAIN WHICH HAS PERSISTED AND HAS CAUSED LIMPING FOR SIX MONTHS. THE PATIENT WAS TOLD BY HER PHYSICIAN THAT IT IS SCIATICA PAIN, RELATED TO A PINCHED NERVE IN HER BACK. THE PATIENT HAD AN MRI AND WAS SEEN BY A NEUROSURGEON, WHO WILL DO FURTHER NERVE TESTING. THE PATIENT STATED THAT A MRI SHOWED KIDNEY CYSTS BUT NOTHING RELATED TO LEG PAIN. THE PATIENT WAS PRESCRIBED NEURONTIN. THE PATIENT EXPERIENCED INTERMITTENT BLOODY URINE, BUT WAS TOLD BY HER UROLOGIST THAT IT WAS NOT CONCERNING UNLESS THERE WERE BLOOD CLOTS PRESENT. THE PATIENT ALSO EXPERIENCED A VAGINAL RASH AND WAS TOLD BY THE PHYSICIAN IT WAS DERMATITIS. THE PATIENT HAS A SLOW STREAM OF URINE BUT INCONTINENCE IS MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302700 GYNECARE TVT ABBREVO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention