BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVIWIPES XL

    MDR report key: 1013884 · Received March 14, 2008

    Report

    Report Number
    1722021-2008-00001
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 26, 2008
    Manufacturer
    METREX RESEARCH CORP.
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL EMPLOYEE WAS EXAMINED BY THE EMT AND PHYSICIAN ON SITE AND WAS NOT TAKEN TO THE HOSPITAL. NO MEDICATION WAS GIVEN AND THE PT WAS FEELING FINE BY THE AFTERNOON. THE PT IS NOW DOING FINE AND HAS BEEN REASSIGNED POSITIONS. IT WAS REPORTED THAT THE HOSPITAL EMPLOYEE WAS CLEANING THE INSIDE OF THE STERILIZER IN A CONFINED AREA WITHOUT THE APPROPRIATE PROTECTION. BECAUSE THE EMPLOYEE LACKED A SENSE OF SMELL SHE WAS OVERCOME WITHOUT WARNING. NO EVALUATION WAS PERFORMED: THE LOT NUMBER INVOLVED WAS UNK, THEREFORE, EVALUATION OF RETAIN SAMPLES COULD NOT BE CONDUCTED. ADDITIONALLY, THE CLINIC DID NOT RETURN ANY SUSPECTED PRODUCT TO METREX RESEARCH CORP FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO METREX RESEARCH CORP THAT ON FEB 22ND WHILE CLEANING THE INSIDE OF A MAGNACLAVE STERILIZER, THE HOSPITAL EMPLOYEE WAS OVERCOME AND PASSED OUT. AN AMBULANCE WAS CALLED AND THE EMPLOYEE WAS EXAMINED ON THE SCENE. THE EMTS AND TREATING PHYSICIAN REPORTED THAT THE PT HAD EXPERIENCED AN ANAPHYLACTIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVIWIPES XL DISINFECTANT, MEDICAL DEVICES LRJ METREX RESEARCH CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other