FDA.reportPublic FDA data

MAUDE MDR 9712184

MDR report key
9712184
Report number
1832415-2020-11106
Event key
0
Event type
3
Date received
2020-02-14
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 EQUIPMENTIRT0550554911Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-140

Event Narratives#

D

Patient 1

CUSTOMER STATED, "WAS USING THE PAD WHEN THE SWITCH SMOKED. CUSTOMER SENT BACK A LETTER STATING THEY TOOK THE UNIT APART TO CONDUCT THEIR OWN INVESTIGATIONS AND THE FINDING THEY FOUND." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED THAT WHEN THE PRODUCT WAS RETURNED THAT THE SWITCH WAS BROKEN APART, ALONG WITH COMPONENTS MISSING. BASED OFF CUSTOMERS SUPPLIED LETTER THE INVESTIGATOR DETERMINED THAT THE USER TOOK APART THE SWITCH TO CONDUCT THEIR OWN INVESTIGATION. ADDITIONALLY THE INVESTIGATOR OBSERVED EVIDENCE OF A SPARK WITHIN THE SWITCH HOUSING WHICH MAY HAVE CAUSED SMOKE THE END USER REPORTED. THE INVESTIGATION WAS INCONCLUSIVE DUE TO THE USER TAKING APART THE UNIT AND NO FAILURE OF THE DEVICE COULD BE DETERMINED. THE IFU STATES, "NEVER ATTEMPT TO OPEN, DISASSEMBLE, OR OTHERWISE ACCESS ANY OF THE PRODUCT'S INTERNAL COMPONENTS. "