BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLCOTRANS PLUS

    MDR report key: 26938 · Received March 16, 1995

    Report

    Report Number
    MW4000698
    Event Type
    Other
    Date Received
    March 16, 1995
    Date of Event
    January 17, 1995
    Report Date
    March 16, 1995
    Manufacturer
    DAVOL BLOOD MGMT PRODUCTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING REINFUSION OF SALVAGED BLOOD PT DEVELOPED SHAKING CHILLS LASTING 10 MINUTES & DEVELOPED FEVER. REINFUSION STOPPED. TEMPERATURE DECREASED WITHIN 1 HR AFTER TYLENOL GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLCOTRANS PLUS Implant AUTOTRANSFUSION (POST OP) CAC DAVOL BLOOD MGMT PRODUCTS 41FEDS28

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other