BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALTHMARKER TIME TEMPERATURE INDICATOR

    MDR report key: 6442345 · Received March 24, 2017

    Report

    Report Number
    MW5068723
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 24, 2017
    Manufacturer
    TEMPTIME CORPORATION
    Product Code
    OCI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTIFIED OF RECENT HOSPITALIZATION FROM INSURANCE CLAIMS. DIAGNOSIS FOR ADMISSION: G40.909 - EPILEPSY UNS NOT INTRACT W/O STATUS EPILEPTICUS. DIAGNOSIS OR REASON FOR USE: R62.52. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214259 HEALTHMARKER TIME TEMPERATURE INDICATOR TRANS TRACKER F (HEAT) OCI TEMPTIME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR