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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infant heel warmer (chemical heat pack)
Product CodeMPO
Regulation Number 890.5710
Device Class 1


Premarket Reviews
ManufacturerDecision
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 8 8
2017 34 34
2018 18 18
2019 8 8
2020 53 53
2021 20 20
2022 61 61
2023 74 74
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 167 167
Explosion 42 42
Material Rupture 23 23
Fluid/Blood Leak 12 12
Leak/Splash 11 11
Break 6 6
Use of Device Problem 5 5
Device Operates Differently Than Expected 4 4
Temperature Problem 4 4
Gel Leak 4 4
Overheating of Device 4 4
Activation Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Activation Failure 2 2
Device Difficult to Setup or Prepare 2 2
Insufficient Heating 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Material Integrity Problem 2 2
Expulsion 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Defective Component 1 1
Component Missing 1 1
Split 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Chemical Spillage 1 1
Activation, Positioning or Separation Problem 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Crack 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Premature Activation 1 1
Material Separation 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 129
No Consequences Or Impact To Patient 45 45
No Known Impact Or Consequence To Patient 33 33
Chemical Exposure 15 15
Insufficient Information 13 13
Burn(s) 7 7
No Information 6 6
Eye Injury 5 6
Foreign Body In Patient 4 4
Burning Sensation 3 3
Burn, Thermal 3 3
Partial thickness (Second Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Skin Irritation 3 3
No Patient Involvement 3 3
Discomfort 3 3
Itching Sensation 2 2
Laceration(s) 2 2
Corneal Abrasion 2 2
Skin Inflammation/ Irritation 2 2
Caustic/Chemical Burns 1 1
Erythema 1 1
Irritation 1 1
Respiratory Distress 1 1
Blurred Vision 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Eye Burn 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jul-17-2023
2 Cardinal Health 200, LLC II Jul-19-2021
3 Philips North America Llc II Jan-19-2022
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