BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSICARE NONLATEX EXAMINATION GLOVES

    MDR report key: 215405 · Received March 18, 1999

    Report

    Report Number
    9615361-1997-00004
    Event Type
    Other
    Date Received
    March 18, 1999
    Date of Event
    June 25, 1997
    Report Date
    March 14, 1999
    Manufacturer
    MAXXIM MEDICAL CANADA, LTD.
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL ASSISTANT REPORTING BREAKING OUT IN HIVES FOLLOWING USE OF SENSICARE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSICARE NONLATEX EXAMINATION GLOVES MEDICAL EXAMINATION GLOVES (PVC) LYZ MAXXIM MEDICAL CANADA, LTD. NA 719SA4/640FB3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other