FDA.reportPublic FDA data

MAUDE MDR 8443723

MDR report key
8443723
Report number
3012316249-2019-00010
Event key
0
Event type
3
Date of event
2019-01-19
Date received
2019-03-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMIPAQUNKNOWNTOPS MEDICAL ARTICLES INDUSTRIES NANTONG INCIME* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2201. O

Event Narratives#

D

Patient 1

END-USER REPORTS THAT SHE USED A HOT AND COLD "PAQ". AS SHE FOLLOWED THE DIRECTIONS AND PLACED THE "PAQ" INTO THE MICROWAVE WHEN THE MICROWAVE ALERTED HER THAT THE PAQ WAS READY, SHE OPENED THE MICROWAVE DOOR AND THE "PAQ" BURST SPRAYING CLAY ALL OVER HER FACE THAT RESULTED IN BURNS. END-USER REPORTS THAT SHE WAS ABLE TO TREAT HER BURNS AT HOME. EXACT ITEM NUMBER IS UNKNOWN, BUT ALL THERMIPAQ INSTRUCTIONS STATE THE FOLLOWING: IMPORTANT: DO NOT EXCEED HEATING TIMES. OVERHEATING WILL DAMAGE THE PAD AND VOID THE WARRANTY. WHILE IN THE MICROWAVE, IF THE PAD BEGINS TO UNFOLD OR IF ANY SWELLING OF THE PAD IS OBSERVED, THEN IMMEDIATELY TURN OFF THE MICROWAVE. WAIT FOR THE SWELLING TO GO DOWN BEFORE OPENING THE MICROWAVE DOOR. THE WATTAGE OF THE MICROWAVE DEPENDS ON THE HEATING TIME. IT IS UNKNOWN THE WATTAGE OF END-USER'S MICROWAVE OR HOW LONG THIS DEVICE WAS HEATED.