FDA.reportPublic FDA data

MAUDE MDR 2586890

MDR report key
2586890
Report number
3003120375-2012-00465
Event key
0
Event type
3
Date received
2012-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
DALTON GA 30721 US
Phone
800-800-8004
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PRECISE PAIN RELIEVING HEAT PATCHADHESIVE BACKED THERMAL SKIN PATCHESKIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTDOMWUNKUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-2201. O

Event Narratives#

D

Patient 1

THIS WAS A SPONTANEOUS REPORT FROM A PHYSICIAN VIA A COMPANY REP AND CONCERNED A PT OF AN UNSPECIFIED AGE AND SEX FROM THE UNITED STATES: (B)(4). THE PT'S HEIGHT, WEIGHT, AND MEDICAL HISTORY WERE NOT REPORTED. THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (TOPICAL, DOSAGE AND FREQUENCY UNSPECIFIED) INITIATED ON AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, "THE PRODUCT CAUSED THE PT'S SKIN TO BURN." ACTION TAKEN WITH PRECISE PAIN RELIEVING HEAT PATCH WAS UNSPECIFIED. THE PT OUTCOME WAS UNSPECIFIED FOR SKIN BURN. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (SERIOUS INJURY).