FDA Adverse Event Malfunction Summary report: N

COMPOUND W FREEZE OFF

MDR report key: 3035879 · Received February 19, 2013

Report

Report Number
1719513-2013-00001
Event Type
Malfunction
Date Received
February 19, 2013
Date of Event
January 29, 2013
Report Date
February 19, 2013
Manufacturer
PRESTIGE BRAND HOLDINGS, INC.
Product Code
GEH
PMA / PMN Number
K032271
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NH, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE ON (B)(6) 2013. THE CONSUMER REPORTS THAT SHE WAS PREPARING TO APPLY THE PRODUCT TO HER FOOT 10 MINUTES PRIOR TO CALLING ON (B)(6) 2013. AS SOON AS SHE DEPRESSED THE BUTTON THE CAN MADE A "WHOOSHING" SOUND AND FLAMES BURST OUT THE TOP OF THE CAN. SHE INSTINCTIVELY THREW THE CAN AWAY FROM HERSELF AND IT LANDED NEXT TO HER SOFA. THE SOFA, PAPERS ON HER COFFEE TABLE, AND CARPET ALL STARTED ON FIRE. SHE THREW HER COFFEE AND WATER ON IT TO PUT FIRE OUT, THEN CALLED HER NEIGHBOUR TO BE SURE IT WAS OUT. SHE PUT THE CAN, WHICH WAS STILL LEAKING OUT THE TOP, INTO HER SINK. THE TOP OF THE CAN IS BURNED. SHE HAS SOOT ON HER FACE AND HANDS, BUT IS UNSURE IF THERE MAY BE MINOR BURNS ON HER HANDS. SHE STATES SHE WAS NOT SMOKING AT THE TIME. TWO FOLLOW-UP ATTEMPTS WERE COMPLETED ON (B)(4) 2013. THE CONSUMER WAS UNABLE TO BE REACHED. FOLLOW-UP INFORMATION RECEIVED FROM THE CONSUMER'S HUSBAND ON (B)(6) 2013. HE REPORTS THAT HIS WIFE DEVELOPED A SMALL BURN TO HER HAND WHEN THE CAN CAUGHT FIRE AND LATER DEVELOPED A SMALL BLISTER ON HER FINGER. THE AFFECTED AREA IS HEALING AND THE REDNESS AND BLISTERING HAS NEARLY RESOLVED. SHE HAS NOT SOUGHT MEDICAL ATTENTION. HE AGAIN DENIED THAT THE PRODUCT WAS NEAR A HEAT SOURCE OR OPEN FLAME AND SUSPECTS THAT A SPARK MAY HAVE BEEN CAUSED BY STATIC ELECTRICITY. THEY HAVE RETAINED THE PRODUCT FOR POSSIBLE RETRIEVAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
72775 COMPOUND W FREEZE OFF DIMETHYL ETHER AND PROPANE GEH PRESTIGE BRAND HOLDINGS, INC. US-CBIGB0010275

Patients

Seq Age Sex Outcome Treatment
1 34 YR Other