BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSICARE EXAMINATION GLOVE

    MDR report key: 215410 · Received March 18, 1999

    Report

    Report Number
    9615361-1997-00002
    Event Type
    Other
    Date Received
    March 18, 1999
    Date of Event
    January 1, 1997
    Report Date
    March 14, 1999
    Manufacturer
    MAXXIM MEDICAL CANADA, LTD.
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VARIOUS REPORTS OF RASH DEVELOPING FOLLOWING USE OF PVC GLOVE. SEVEN STAFF MEMBERS REPORTEDLY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSICARE EXAMINATION GLOVE MEDICAL EXAMINATION GLOVE (PVC) LYZ MAXXIM MEDICAL CANADA, LTD. NA 707FA4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other