THERMOPHORE 156

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 2020-03-04 for THERMOPHORE 156 manufactured by Battle Creek Equipment.com.

MAUDE Entry Details

Report Number1832415-2020-11174
MDR Report Key9786404
Report SourceCONSUMER
Date Received2020-03-04
Date of Report2020-02-10
Date Added to Maude2020-03-04
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 Received2020-03-04
Returned To Mfg2020-02-14
Model Number156
Lot Number00156347181
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBATTLE CREEK EQUIPMENT.COM
Manufacturer Address702 S REED RD FREMONT, IN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.