BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NDO SURGICAL PLICATOR,

    MDR report key: 1276007 · Received December 29, 2008

    Report

    Report Number
    MW5009449
    Event Type
    Injury
    Date Received
    December 29, 2008
    Date of Event
    January 11, 2007
    Report Date
    December 28, 2008
    Manufacturer
    NDO SURGICAL
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS TO BE A 20 MIN PROCEDURE THAT WENT WRONG - ONLY TWO SUTURES WERE TO BE USED TO TIGHTEN PLICA. IN EARLY 2007, AT 1:00 PM, PLICATOR WAS USED TO CURE REFLUX BECAME LODGED IN ABDOMEN - TWO HR CONFERENCE CALLS. TWO SURGEONS WERE CALLED IN TO REMOVE PLICATOR, SURGERY TOOK 5-1/2 HRS. I HAD TO BE CUT FROM STERNUM TO NAVEL WHICH TOOK 29 STAPLES - SURGERY ENDED AT 7:30 PM. LOST UPPER PORTION OF STOMACH - PATHOLOGY BENIGN. WAS ADMITTED TO THE ST. HOSPITAL CAMPUS CARDIOVASCULAR ICU FOR ABOUT 6 DAYS ON VENTILATOR. WAS A NEAR DEATH EXPERIENCE. SUFFERED TRAUMATIC SPLENIC INJURY. SUFFERED STAB WOUND FROM PLICATOR INSIDE ABDOMEN WHICH PROTRUDED OUT OF RIGHT SIDE OF ABDOMEN. HAVE VOICE BOX DAMAGE, DIFFICULTY SPEAKING CLEARLY. UNCONSCIOUSLY DRESSED BY SOMEONE, PROPPED UP IN A WHEELCHAIR AND AMBULATED TO REHAB EIGHTEEN DAYS LATER. THREE DAYS PRIOR, DUE TO COMPLICATIONS, WAS ADMITTED TO OTHER HOSPITAL FACILITY FOR 4 DAYS DUE TO LEFT COLLAPSED LUNG. PNEUMONIA - REQUIRED BLOOD TRANSFUSION - WRONGFUL GAS BLOOD DRAW SHOT WAS DONE WHICH CAUSED RADIAL NERVE DAMAGE TO RIGHT HAND/ARM - HAVE LOST NORMAL USE OF RIGHT HAND/ARM - THIS DAMGE HAS SERIOUSLY AFFECTED MY PRINTING/WRITING. A MONTH AFTER THE ORIGINAL DATE, WAS ONCE AGAIN ADMITTED TO OTHER HOSPITAL FACILITY, FOR 24 HRS, FOR PROJECTILE VOMITING DUE TO TRANSITION OF IV MEDICATIONS TO ORAL MEDS - CHEMOTHERAPY NAUSEA MEDICATION WAS USED TO STOP THE VOMITING. WAS HOSPITALIZED FOR NINE DAYS FROM ORIGINAL DATE, AND IN REHAB FOR APPROX TWO MONTHS, THIS PLICATOR ADVERSE EVENT HAS BEEN SEROUS EXACERBATION TO MY HEALTH AND HAS LEFT ME WITH THE FOLLOWING DISABILITIES: LOSS OF THE UPPER PORTION OF MY STOMACH; RIGHT HAND RADIAL NERVE DAMAGE DUE TO WRONGFUL GAS BLOOD DRAW SHOT AT OTHER HOSPITAL FACILITY DUE TO COMPLICATIONS CAUSED BY PLICATOR ADVERSE EVENT; TRAUMATIC SPLENIC INJURY; RUINED MY STOMACH MUSCLES DUE TO HAVING TO BE CUT FROM STERNUM TO NAVAL; AND VOICE BOX DAMAGE - I HAVE DIFFICULTY SPEAKING CLEARLY. I CONTINUE TO HAVE REFLUX (GERD) - IT HAS WORSENED - I NOW HAVE TO TAKE 60 MG OF PREVACID A DAY INSTEAD OF ONSET OF REFLUX 30 MG PER DAY. DATES OF USE: 2007. DIAGNOSIS: REFLUX (GERD). EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDO SURGICAL PLICATOR, PLICATOR KOG NDO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Hospitalization| L| O| R| S