FDA Adverse Event Summary report: N

COMPOUND W FREEZE OFF

MDR report key: 2707782 · Received August 15, 2012

Report

Report Number
1719513-2012-00001
Date Received
August 15, 2012
Date of Event
August 6, 2012
Report Date
August 14, 2012
Manufacturer
PRESTIGE BRAND HOLDINGS, INC.
Product Code
GEH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, 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) 2012. THE CONSUMER REPORTS THAT SHE APPLIED THE PRODUCT TO A WART ON HER RIGHT WRIST, LEFT WRIST, LEFT ELBOW, AND JUST BELOW HER RIGHT KNEE ON APPROX (B)(6) 2012. SHE STATES THAT SHE WOKE UP THE FOLLOWING MORNING WITH A BURNING SENSATION ON THE APPLICATIONS SITES. SHE APPLIED AN UNK BURN CREAM SHE RECEIVED FROM HER SON, WHICH HELPED RELIEVE THE BURNING SENSATION, BUT SHE NOW HAS OPEN AREAS OF SKIN WHERE SHE APPLIED THE PRODUCT. CALLER HAS DIAGNOSED HERSELF WITH 3 SECOND DEGREE BURNS (LEFT ELBOW, LEFT WRIST, JUST BELOW RIGHT KNEE) AND 1 THIRD DEGREE BURN IN WHICH SHE STATES THE EXPOSED SKIN HAS TURNED BLACK AND SHE HAS BEEN CLEANING IT WITH A TWEEZERS IN RUBBING ALCOHOL. SHE HAS NOT YET BEEN EVALUATED BY A PHYSICIAN AND WAS SUBSEQUENTLY ADVISED TO DO SO. FOLLOW-UP INFO RECEIVED VIA PHONE ON (B)(6) 2012, WHICH UPGRADED THE CASE STATUS TO SERIOUS. THE CONSUMER REPORTS THAT SHE WENT TO SEE A PHYSICIAN ON (B)(6) 2012. THE PHYSICIAN APPARENTLY DIAGNOSED THE OPEN AREAS ON HER LEFT ELBOW, LEFT WRIST, AND JUST BELOW THE RIGHT KNEE AS SECOND DEGREE BURNS AND THE OPEN AREA OF SKIN ON HER RIGHT WRIST AS A THIRD DEGREE BURN. THE PHYSICIAN PRESCRIBED BACTROBAN AND TOLD HER TO LEAVE THE AREAS OPEN TO HELP THEM HEAL. THE PHYSICIAN ALSO APPARENTLY INFORMED HER THAT SHE MAY HAVE PERMANENT SCARS FROM THE OPEN AREAS OF SKIN. SHE REPORTS THAT THE OPEN AREAS STILL HURT WHEN SHE GETS WATER IN THEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMPOUND W FREEZE OFF DIMETHYL ETHER AND PROPANE GEH PRESTIGE BRAND HOLDINGS, INC. US-CAIGB-2088

Patients

Seq Age Sex Outcome Treatment
1 65 YR