TPLC - Total Product Life Cycle

• Device: bedding, disposable, medical
• Product Code: KME
• Regulation Number: 880.6060
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2015	2	2
2016	2	2
2017	6	6
2019	7	7
2020	5	5
2021	2	2
2022	1	1
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3	3
Insufficient Information	3	3
Material Split, Cut or Torn	3	3
Material Integrity Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Fragmentation	2	2
Excess Flow or Over-Infusion	1	1
Device Emits Odor	1	1
Off-Label Use	1	1
Device Slipped	1	1
Inadequate or Insufficient Training	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Incomplete or Missing Packaging	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Torn Material	1	1
Patient Device Interaction Problem	1	1
Component Falling	1	1
Contamination	1	1
Deflation Problem	1	1
Material Disintegration	1	1
Display or Visual Feedback Problem	1	1
Accessory Incompatible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	5	5
No Known Impact Or Consequence To Patient	5	5
Fall	4	4
No Clinical Signs, Symptoms or Conditions	3	3
Rash	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Injury	2	2
Hip Fracture	1	1
Fracture, Arm	1	1
Burn, Thermal	1	1
Caustic/Chemical Burns	1	1
No Information	1	1
Skin Burning Sensation	1	1
Localized Skin Lesion	1	1
Skin Inflammation/ Irritation	1	1
Swelling	1	1
Vomiting	1	1
No Consequences Or Impact To Patient	1	1
Head Injury	1	1
Hematoma	1	1
Itching Sensation	1	1
Adult Respiratory Distress Syndrome	1	1
Burn(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LITTLE RAPIDS CORPORATION	II	Jan-09-2018
2	Microtek Medical Inc.	II	Jul-28-2023