THERMACARE LOWER BACK & HIP

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 2020-03-24 for THERMACARE LOWER BACK & HIP manufactured by Pfizer Consumer Health Care.

MAUDE Entry Details

Report Number1066015-2020-00080
MDR Report Key9874007
Report SourceCONSUMER
Date Received2020-03-24
Date of Report2020-03-11
Date of Event2020-03-10
Date Added to Maude2020-03-24
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 ContactMRS STELLA PIETRAFESA
Manufacturer Street235 E42ND STREET
Manufacturer CityNEW YORK NY 10017
Manufacturer CountryUS
Manufacturer Postal10017
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMACARE LOWER BACK & HIP
Generic NameDISPOSABLE PACK, HOT
Product CodeIMD
Date Received2020-03-24
Lot NumberF26176B
Device Expiration Date2014-04-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPFIZER CONSUMER HEALTH CARE
Manufacturer Address1231 WYANDOTTE DRIVE ALBANY GA 31705 US 31705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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