BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND GRIP PLUS

    MDR report key: 255719 · Received December 22, 1999

    Report

    Report Number
    2939513-1999-00003
    Event Type
    Injury
    Date Received
    December 22, 1999
    Date of Event
    November 17, 1999
    Report Date
    December 16, 1999
    Manufacturer
    OMNIGRACE(THAILAND) LTD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 12/14/1999 IT WAS BROUGHT TO DISTRIBUTORS ATTENTION THAT AN ADVERSE REACTION HAD OCCURRED ON 11/17/1999. THE EVENT INVOLVED A FEMALE CLINICIAN WHO WORE LATEX GLOVES EXPERIENCED SWELLING OF HANDS, ALONG WITH CRACKED SKIN AND BLISTERS. THE ADVERSE REACTION WAS LOCALIZED TO THE HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND GRIP PLUS OMNIGRACE RUBBER LATEX PATIENT EXAMINATION GLOVE LYY OMNIGRACE(THAILAND) LTD DGP-350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability