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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
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 53 53
2021 20 20
2022 61 61
2023 74 74
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 140 140
Explosion 43 43
Material Rupture 20 20
Fluid/Blood Leak 10 10
Leak/Splash 6 6
Break 4 4
Gel Leak 4 4
Temperature Problem 4 4
Activation Problem 3 3
Device Difficult to Setup or Prepare 2 2
Activation Failure 2 2
Activation, Positioning or Separation Problem 1 1
Material Puncture/Hole 1 1
Insufficient Information 1 1
Defective Component 1 1
Defective Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Material Separation 1 1
Appropriate Term/Code Not Available 1 1
Insufficient Heating 1 1
Unexpected Therapeutic Results 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
No Consequences Or Impact To Patient 40 40
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 15 15
Chemical Exposure 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 2 2
Skin Inflammation/ Irritation 2 2
Burn(s) 2 2
Discomfort 2 2
Laceration(s) 2 2
Skin Irritation 1 1
Corneal Abrasion 1 1
Eye Burn 1 1
Erythema 1 1
Unspecified Eye / Vision Problem 1 1
Eye Injury 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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