FDA.reportPublic FDA data

MAUDE MDR 259652

MDR report key
259652
Report number
1018233-2000-00002
Event key
0
Event type
3
Date received
2000-01-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD ECONOMY HEATING PADHEATING PADC.R. BARD, INC.IRTNA02 8103120UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-01-2001. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE HEATING PAD WAS FOUND BURNING IN AN UNOCCUPIED BED. PT HAD BEEN USING PAD FOR AN UNDETERMINED AMOUNT OF TIME PRIOR TO DISCHARGE. DURING USE, PAD HAD BEEN FOLDED IN SUCH A WAY THAT THE PT LUCKILY WAS NOT BURNED. PAD BURNED THROUGH BOTH SIDES THAT WERE FOLDED. IT IS UNCLEAR WHEN PAD WAS ISSUED OR FOR WHAT INTERVALS IT WAS USED.