BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX EX GLOVES

    MDR report key: 29123 · Received December 7, 1995

    Report

    Report Number
    1417592-1995-07386
    Event Type
    Injury
    Date Received
    December 7, 1995
    Report Date
    December 7, 1995
    Manufacturer
    MEDLINE IND.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, NURSES EXPERIENCED RED ITCHY RASH WHILE USING LATEX EXAM GLOVES. UNK IF MEDICAL TREATMENT WAS REQUIRED. UNABLE TO IDENTIFY MFR WITH LOT NUMBER PROVIDED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: .INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX EX GLOVES LATEX EXAMINATION GLOVES LYY MEDLINE IND. 94061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention