THERMOPHORE 056

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for THERMOPHORE 056 manufactured by Battle Creek Equipment.

Event Text Entries

[180777827] Customer stated, " was using pad and smelled something funny. Took the cover off and noticed burn marks on the pad. " customer did not claim injury. Product was returned. The investigator found no evidence of burn marks. The investigator observed that the user was misusing the pad by laying on the pad. This was determined by the bent and broken leads in the pad. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1832415-2019-10979
MDR Report Key9545656
Report SourceCONSUMER
Date Received2020-01-03
Date of Report2019-12-05
Date Added to Maude2020-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL GREEN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMOPHORE
Generic NameTHERMOPHORE
Product CodeIRT
Date Received2020-01-03
Returned To Mfg2019-12-26
Model Number056
Lot Number00056033191
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBATTLE CREEK EQUIPMENT
Manufacturer Address702 S REED RD FREMONT IN 46737 US 46737


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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