BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 7088800 · Received December 6, 2017

    Report

    Report Number
    3012307300-2017-02062
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    January 1, 2017
    Report Date
    March 11, 2024
    Manufacturer
    ST PAUL
    Product Code
    DWJ
    UDI-DI
    50695085000653
    PMA / PMN Number
    K011907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: G3: FRANCE. CONCOMITANT MEDICAL PRODUCTS: LEVEL 1 SNUGGLE WARM BLANKET, LEVEL 1 EQUATOR. LOT NUMBER NOT PROVIDED: D4 LOT NUMBER, EXPIRATION DATE, AND H4: UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.H3: DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER. FOR ALL ENQUIRES OR FOLLOW UP QUESTIONS RELATED TO THE RECORD, DO NOT USE (B)(6) LOCATED IN SECTIONS D3 AND G1, PLEASE DIRECT THOSE TO THE FOLLOWING: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF A THE DEVICE, THE PATIENT SUSTAINED A BURN. THE SEVERITY AND LOCATION OF THE BURN ARE UNKNOWN AT THIS TIME. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869161 LEVEL 1 SYSTEM, THERMAL REGULATING DWJ ST PAUL 50695085000653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown