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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
2018 18 18
2019 8 8
2020 53 53
2021 20 20
2022 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 76 76
Explosion 42 42
Material Rupture 16 16
Fluid/Blood Leak 9 9
Break 5 5
Leak/Splash 4 4
Temperature Problem 3 3
Activation Problem 3 3
Gel Leak 2 2
Overheating of Device 2 2
Activation Failure 2 2
Insufficient Heating 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Material Perforation 1 1
Component Missing 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1
Unexpected Therapeutic Results 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Hole In Material 1 1
Material Separation 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
No Consequences Or Impact To Patient 43 43
No Known Impact Or Consequence To Patient 25 25
Insufficient Information 13 13
Chemical Exposure 5 5
No Patient Involvement 3 3
Laceration(s) 2 2
Skin Irritation 2 2
No Information 2 2
Eye Burn 1 1
Burn(s) 1 1
Fluid Discharge 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Erythema 1 1
Burning Sensation 1 1
Injury 1 1
Burn, Thermal 1 1
Eye Injury 1 1

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