TPLC - Total Product Life Cycle

• Device: pack, hot or cold, reusable
• Product Code: IME
• Regulation Number: 890.5700
• Device Class: 1

MDR Year	MDR Reports	MDR Events
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	11	11
Burst Container or Vessel	5	5
Temperature Problem	3	3
Use of Device Problem	3	3
Patient-Device Incompatibility	2	2
Fire	2	2
Overheating of Device	2	2
Explosion	2	2
Excessive Heating	2	2
Material Split, Cut or Torn	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Labelling, Instructions for Use or Training Problem	1	1
Melted	1	1
Human-Device Interface Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Handling Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	12	12
Partial thickness (Second Degree) Burn	7	7
Erythema	5	5
No Known Impact Or Consequence To Patient	4	4
Superficial (First Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Blister	2	2
Burning Sensation	2	2
Skin Irritation	2	2
Swelling	2	2
Burn, Thermal	2	2
Caustic/Chemical Burns	1	1
Visual Impairment	1	1
Anxiety	1	1
Discomfort	1	1
Injury	1	1
Numbness	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Unspecified Infection	1	1
Itching Sensation	1	1
Pain	1	1
Rash	1	1
Red Eye(s)	1	1
Scar Tissue	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
No Information	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