FDA.reportPublic FDA data

MAUDE MDR 1981142

MDR report key
1981142
Report number
MW5019269
Event key
0
Event type
3
Date of event
2010-11-20
Date received
2011-02-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMACARE HEATWRAPSMENSTRUAL CRAMP HEATWRAPSWYETH CONSUMER HEALTHCAREOMW**E06831S Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-0201. O; 2. R

Event Narratives#

D

Patient 1

ON (B)(6), 2010, I USED THERMACARE HEATWRAPS MENSTRUAL LOT NUMBER E06831S. WHEN I REMOVED THE WRAP, I NOTICED THAT I HAD TWO QUARTER SIZED RED PATCHES WHERE THE PATCH HAD TOUCHED MY LOWER ABDOMEN. THE TWO PATCHES BEGAN ITCHING AND THE SKIN BUBBLED UP. I BELIEVE BOTH PATCHES WERE THIRD DEGREE BURNS. I HAD TO TREAT THE AREAS FOR ABOUT A MONTH. I NOW HAVE TWO SCARS WHERE THE BURNS OCCURRED. USED 6 HOURS FOR MENSTRUAL CRAMPS.