BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN 100U/ML 1-3ME

    MDR report key: 1022095 · Received April 11, 2008

    Report

    Report Number
    MW5006076
    Event Type
    Other
    Date Received
    April 11, 2008
    Date of Event
    February 20, 2008
    Manufacturer
    MEDEFIL, INC
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND WAS DIAGNOSED WITH GBS IN 2008. HE HAD IVIG TREATMENT AND WE HAD FLUSH THE PORT WITH HEPARIN BEFORE EACH TREATMENT. HE HAS HAD A RASH WHICH HAS TRAVELED TO DIFFERENT PARTS OF HIS BODY BEGINNING ON HIS TRUNK, SPREAD TO HIS ARMS AND LEGS, THE FEET AND PALMS OF HIS HANDS. HE STARTED ON PREDNISONE ABOUT 6 WEEKS AFTER DIAGNOSIS, AND HAS JUST FINISHED HIS SECOND WEEK. THE RASH IS RETURNING. HE ALSO HAS A 'BURNING" SENSATION IN HIS LOWER BACK. WE THINK IT IS A POSSIBLE REACTION TO THE RECALLED HEPARIN. HEALTHCARE CALLED TO CHECK ON HIM BUT WE DID NOT THINK OF THE LINK TO THE HEPARIN AND THE RASH AT THAT TIME. IVIG WAS ADMINISTERED BY HEALTHCARE. DOSE OR AMOUNT: 1-3 ME. FREQUENCY: PRE/POST INFUSION. ROUTE: INTRA-ARTERY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: GBS/ACUTE INFECTIVE POLYNEURITIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO. EVENT REAPPEARED AFTER REINTRODUCTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 100U/ML 1-3ME NONE NZW MEDEFIL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other