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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
Regulation Description Cold pack.
Product CodeIME
Regulation Number 890.5700
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 6 6
2022 6 6
2023 5 5
2024 12 12
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Burst Container or Vessel 2 2
Excessive Heating 2 2
Overheating of Device 2 2
Temperature Problem 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 1 1
Fire 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
Material Rupture 1 1
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
No Apparent Adverse Event 1 1
Explosion 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Human-Device Interface Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 13 13
Partial thickness (Second Degree) Burn 8 8
Erythema 4 4
Full thickness (Third Degree) Burn 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blister 3 3
Skin Irritation 2 2
Swelling 2 2
Unspecified Tissue Injury 2 2
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Red Eye(s) 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Inflammation 1 1
Itching Sensation 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1
Rash 1 1
Burning Sensation 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Pain 1 1
Scar Tissue 1 1
Visual Impairment 1 1
Anxiety 1 1
Caustic/Chemical Burns 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Skin Burning Sensation 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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