WARMING CABINET BW7924TG

Additional Manufacturer Narrative

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

(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."