BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTEMP PLUS

    MDR report key: 180 · Received January 29, 1992

    Report

    Report Number
    180
    Event Type
    Injury
    Date Received
    January 29, 1992
    Date of Event
    December 29, 1991
    Report Date
    January 9, 1992
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SKIN BREAKDOWN ON INFANT'S ABDOMEN AT SITE OF TEMPERATURE PROBEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: NO. CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTEMP PLUS TEMPERATURE PROBE COVERS FLL KENTEC MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention