BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WARMING CABINET BW7924TG

    MDR report key: 12440769 · Received September 8, 2021

    Report

    Report Number
    0002244019-2021-00001
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    July 6, 2020
    Report Date
    September 2, 2021
    Manufacturer
    BLICKMAN INDUSTRIES LLC
    Product Code
    LHC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BLANKET WARMER WAS NOT MANUFACTURED BY BLICKMAN INDUSTRIES LLC. BLICKMAN INDUSTRIES, LLC, ACQUIRED THE OPERATING ASSETS OF BLICKMAN, INC. ON DECEMBER 21, 2017. SPECIFICALLY, THE PURCHASE AGREEMENT REQUIRED BLICKMAN INC. TO RETAIN RESPONSIBILITY FOR ALL PREVIOUSLY DISTRIBUTED PRODUCTS. BLICKMAN INDUSTRIES, LLC MAINTAINS REPORTING RESPONSIBILITY FOR THE MEDICAL DEVICES MANUFACTURED AND DISTRIBUTED BY BLICKMAN INDUSTRIES, LLC. BLICKMAN INDUSTRIES, LLC WILL ABIDE WITH THE REPORTING REQUIREMENTS FOR THIS OBSERVATION, BUT THAT BASED ON THE FDA MEDICAL DEVICE REPORTING REQUIREMENTS, WE DO NOT RETAIN RESPONSIBILITY. THIS IS SUPPORTED BY FDA MEDICAL DEVICE REPORTING FOR MANUFACTURERS. GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF. DOCUMENT ISSUED ON: NOVEMBER 8. 2016. SECTION 4.12 MANUFACTURER CEASED MARKETING A DEVICE. BLICKMAN INC. IMPLEMENTED AN IMPROVED DEBURRING STEP TO BW MANUFACTURING ON 05-26-11. THE INTENTION OF THIS ADDITIONAL STEP WAS TO FURTHER REDUCE THE PROBABILITY THAT A SHARP EDGE COULD OCCUR DURING THE PUNCH-HOLE PROCESS.

    Description of Event or Problem · 1

    (B)(6) REPORTED, "I JUST GOT A CALL FROM (B)(6) FROM (B)(6). HE SAID THAT HE RECEIVED SOME COMPLAINTS ABOUT NURSES GETTING CUT FROM THE SIDE VENTS WHEN USING THE BLANKET WARMER. HE HAD NOT CHECKED THAT WARMER IN QUESTION BUT WAS ABLE TO CONFIRM VERY SHARP EDGES ON A SEPARATE WARMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338045 WARMING CABINET BW7924TG WARMER, IRRIGATION SOLUTION LHC BLICKMAN INDUSTRIES LLC 7924TG 007334, 007605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention