BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPRACTICE ECONOMY EXAMINATION GLOVES

    MDR report key: 6176 · Received June 25, 1993

    Report

    Report Number
    2083595-1993-00001
    Event Type
    Injury
    Date Received
    June 25, 1993
    Date of Event
    May 10, 1993
    Report Date
    May 13, 1993
    Manufacturer
    TOMARC (M) SDN. BHD.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DR.'S OFFICE REPORTED POSSIBLE PATIENT REACTION. 5/10;/93 6:30 P.M.-EXAM PERFORMED ON 40 YEAR OLD MALE PATIENT. FLOURIDE TREATMENT GIVEN. (PATIENT NOTED DIFFERENT FLOURIDE USED THIS VISSIT.) PATIENT RETURNED HOME AND AT APPROX. 8:00 P.M. EXPERIENCED NAUSEA AND LOSS OF SPEECH DUE TO THROAT SWELLING. THIS REACTION LASTED APPROX. 30-40 MINUTES. THE PATIENT'S PRIMARY PHYSICIAN WHO MENTIONED A POSSIBLE FLOURIDE, LATEX OR GLOVE POWDER REACTION. PATIENT DID NOT SEEK FURTHER TREATMENT AT THE TIME OF THIS REPORTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED, USER EDUCATION PROVIDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPRACTICE ECONOMY EXAMINATION GLOVES LATEX EXAMINATION GLOVES LYY TOMARC (M) SDN. BHD. N/A 921017

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other