FAT FREEZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for FAT FREEZER manufactured by Unk.

Event Text Entries

[135427737] I used the fat freezer i purchased online exactly as directed, and was left with a red mark larger than a silver dollar which i still have (though faded) three weeks later. It itched constantly for the first week.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083572
MDR Report Key8293223
Date Received2019-01-29
Date of Report2019-01-26
Date of Event2019-01-05
Date Added to Maude2019-01-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFAT FREEZER
Generic NameFAT FREEZER
Product CodeOOK
Date Received2019-01-29
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-29

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