BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABY QUASAR

    MDR report key: 1692102 · Received May 14, 2010

    Report

    Report Number
    3006182559-2010-00001
    Event Type
    Injury
    Date Received
    May 14, 2010
    Date of Event
    April 17, 2010
    Report Date
    May 14, 2010
    Manufacturer
    QUASAR BIO-TECH, INC.
    Product Code
    ILY
    PMA / PMN Number
    K051046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ADMITTED SHE FELL ASLEEP WITH THE UNIT ON AND USED THE HEAT DEVICE MUCH LONGER THAN SHE SHOULD HAVE ACCORDING TO THE INSTRUCTIONS FOR USE. WHEN WE ASKED FOR THE PRODUCT TO BE RETURNED, SHE AGREED IF WE WOULD SEND A REPLACEMENT, WHICH WE DID. SHE IS A SATISFIED USER AND WILL CONTINUE TO USE THE BABY QUASAR.

    Description of Event or Problem · 1

    USER FELL ASLEEP USING THE BABY QUASAR AND WOKE UP THREE HOURS LATER WITH A BLISTERED BURN ON HER CHEEK. SHE APPLIED COLD WATER IMMEDIATELY AND WENT TO THE ER. SHE FOLLOWED UP HER ER VISIT WITH SEVERAL VISITS TO A WOUND CARE SPECIALIST. ON (B) (6) 2010 - ER VISIT. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY QUASAR BABY QUASAR ILY QUASAR BIO-TECH, INC. BQ101 2225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention