FDA Adverse Event Injury Summary report: N

KAZ/HONEWELL

MDR report key: 4894958 · Received June 30, 2015

Report

Report Number
MW5043547
Event Type
Injury
Date Received
June 30, 2015
Date of Event
June 20, 2015
Report Date
June 20, 2015
Manufacturer
HONEYWELL
Product Code
IME
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

HELLO. I'D BEEN USING THE SMART TEMP PACK MADE BY THE K A Z DIVISION OF HONEYWELL, AS FAR AS I CAN TELL FROM THE ONLINE INFORMATION, FOR 2 WEEKS AND FOUND IT EXCELLENT ESPECIALLY AS AN ICE PACK. THE COVERING FROM THE PACK WORKED SOMEWHAT WELL ALTHOUGH THE PACK TENDED TO SLIP OUT OF THE COVERING AND MAKE IT EASY FOR THE EDGE OF THE PACK TO BURN MY BACK. BUT THE (B)(6) ATTACHMENT DEVICE WAS ALSO USEFUL. THE FIRST FOUR OR FIVE TIMES I USED IT AS A HEAT PACK IT WAS OTHERWISE FINE. LAST NIGHT I HEATED IT IN THE SAME MICROWAVE AND IT EXPLODED. I REALIZED AFTERWARD THAT I HAD HEARD A POP BUT WAS ATTENDING TO OTHER THINGS IN THE KITCHEN AND DIDN'T RECOGNIZE WHAT I HAD HEARD. NOR DID I REALIZE AT FIRST THAT THERE WAS A HOLE THAT WAS LEAKING GEL UNTIL I GOT HOT BURNING GEL ALL OVER MY HANDS. OF COURSE THE PACK IS NOW UN-USABLE. ALTOGETHER, THIS SEEMS TO ME AN INEXCUSABLE FLAW IN A PRODUCT, THAT MAKES IT VERY DANGEROUS. NOTE: THIS IS THE LAST THING I NEEDED SINCE I AM SUFFERING FROM MANY AILMENTS, AND AT THE MOMENT FROM EXCRUCIATING BACK SPASMS. SO RIGHT NOW I'M WITHOUT ANY HEATING PRODUCT TO HELP ME. MY (B)(6) IS EXTREMELY LIMITED AND THIS WAS A MAJOR PURCHASE FOR ME. I HAVE WRITTEN TO THE COMPANY TO COMPLAIN AND GET MONEY BACK. I DON'T HAVE THE PACKAGING OR RECEIPT ANYMORE. I DON'T KNOW WHAT RESPONSE I'LL GET. IT'S ALSO HARD FOR ME TO GET OUT OF THE HOUSE TO SHOP FOR A NEW APPROPRIATE PRODUCT WHICH I'D RATHER NOT BUY ONLINE (SHIPPING COSTS, ETC); I WANT TO EXAMINE AND MAKE SURE IS SAFE. PRODUCT DESCRIPTION: SMART TEMP MODEL THERAPEUTIC PACK FOR FREEZER OR MICROWAVE. COMES WITH COVER THAT WORKS WITH SOME FLAWS LETTERING YOU END UP BURNED BY PRODUCT INADVERTENTLY. ALSO WITH (B)(6) BELT TO LET YOU KEEP THE PRODUCT POSITIONED. RETAILER: (B)(6). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
420459 KAZ/HONEWELL MICROWAVE PACK IME HONEYWELL UNK

Patients

Seq Age Sex Outcome Treatment
1 59 YR