FDA.reportPublic FDA data

MAUDE MDR 9545665

MDR report key
9545665
Report number
1832415-2019-10983
Event key
0
Event type
3
Date received
2020-01-03
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
MICHAEL GREEN
Address
US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMOPHORETHERMOPHOREBATTLE CREEK EQUIPMENTIRT15500155037193Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-030

Event Narratives#

D

Patient 1

CUSTOMER STATED, "PAD WILL NOT SHUT OFF." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. INVESTIGATOR DETERMINED THROUGH TESTING THAT THE SWITCH WHEN PUT IN THE OFF POSITION WOULD STILL RETURN TO DRAWING POWER AS IF ON THE HIGH SETTING. FURTHER INVESTIGATION WILL BE CONDUCTED BY SWITCH MANUFACTURER, ALONG WITH A FOLLOW UP REPORT SUBMITTED.