TPLC - Total Product Life Cycle

• Device: fiber, medical, absorbent
• Product Code: FRL
• Regulation Number: 880.5300
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	13	13
2020	26	26
2021	13	13
2022	4	4
2023	6	6
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	13	13
Material Separation	12	12
Contamination /Decontamination Problem	12	12
Material Integrity Problem	6	6
Device Contamination with Chemical or Other Material	5	5
Material Frayed	5	5
Contamination	3	3
Material Discolored	2	2
Flaked	2	2
Device Reprocessing Problem	2	2
Failure to Clean Adequately	2	2
Fluid/Blood Leak	1	1
Delivered as Unsterile Product	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Degraded	1	1
Improper Flow or Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
No Apparent Adverse Event	1	1
Difficult to Open or Remove Packaging Material	1	1
Problem with Sterilization	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21	21
No Known Impact Or Consequence To Patient	18	18
No Consequences Or Impact To Patient	9	9
Foreign Body In Patient	8	8
Missing Value Reason	3	3
Insufficient Information	3	3
Local Reaction	2	2
No Information	2	2
No Patient Involvement	2	2
Unspecified Infection	1	1
Inflammation	1	1
Rash	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Foreign Body Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medline Industries Inc	II	Jul-16-2021