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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vapocoolant device
Product CodeMLY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
623 MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRYOSCIENCE NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEBAUER COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ITW CONTAMINATION CONTROL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
OCCAM DESIGN
  SUBSTANTIALLY EQUIVALENT 1
VAPOCOOLSHOT, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 1 1
2018 2 2
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 2 2
Fire 2 2
Off-Label Use 1 1
Burst Container or Vessel 1 1
Unintended Ejection 1 1
Device Operates Differently Than Expected 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
No Information 1 1
Cryogenic Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Asthma 1 1
Burn(s) 1 1
Edema 1 1
Pain 1 1
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Reaction, Injection Site 1 1

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