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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pack, hot or cold, reusable
Product CodeIME
Regulation Number 890.5700
Device Class 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 11 11
2016 24 24
2017 15 15
2018 17 17
2019 11 11
2020 9 9
2021 6 6
2022 6 6
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Burst Container or Vessel 11 11
Leak/Splash 10 10
Fire 9 9
Overheating of Device 8 8
Use of Device Problem 8 8
Temperature Problem 6 6
Insufficient Information 5 5
Device Operates Differently Than Expected 4 4
Improper or Incorrect Procedure or Method 4 4
Patient-Device Incompatibility 4 4
Device Emits Odor 3 3
Melted 3 3
Thermal Decomposition of Device 3 3
Device Handling Problem 3 3
Explosion 2 2
Excessive Heating 2 2
Break 2 2
Material Separation 2 2
Defective Device 2 2
Physical Property Issue 2 2
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Packaging Compromised 1 1
Excessive Cooling 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Moisture or Humidity Problem 1 1
Chemical Spillage 1 1
Nonstandard Device 1 1
Defective Component 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Charred 1 1
Fluid/Blood Leak 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Split, Cut or Torn 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 27 27
Burn(s) 25 25
Burn, Thermal 14 14
No Known Impact Or Consequence To Patient 14 14
Full thickness (Third Degree) Burn 9 9
Pain 7 7
Erythema 5 5
No Consequences Or Impact To Patient 5 5
Superficial (First Degree) Burn 5 5
Burning Sensation 4 4
Swelling 3 3
Injury 3 3
No Information 3 3
Rash 3 3
Scar Tissue 2 2
Itching Sensation 2 2
Hypersensitivity/Allergic reaction 2 2
Blister 2 2
Skin Irritation 2 2
Complaint, Ill-Defined 2 2
Caustic/Chemical Burns 2 2
Chemical Exposure 1 1
Visual Impairment 1 1
Joint Swelling 1 1
Numbness 1 1
Anxiety 1 1
Discomfort 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Unspecified Infection 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Gangrene 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Nerve Damage 1 1
Perforation 1 1
Scarring 1 1
Skin Discoloration 1 1
Local Reaction 1 1
Red Eye(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Nov-07-2022
2 KT Health, LLC II Apr-21-2020
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-09-2022
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