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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device thermometer, clinical color change
Product CodeFQZ
Regulation Number 880.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
BRYMILL CRYOGENIC CYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 1 1
Caustic/Chemical Burns 1 1
Superficial (First Degree) Burn 1 1
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BearCare, Inc. I Jun-08-2023
2 Medical Indicators, Inc. II Sep-06-2013
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