TPLC - Total Product Life Cycle

• Device: gauze/sponge, internal
• Product Code: EFQ
• Device Class: Unclassified

MDR Year	MDR Reports	MDR Events
2018	7	7
2019	5	5
2020	8	8
2021	6	6
2022	6	6
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	6	6
Material Separation	4	4
Component Missing	4	4
Packaging Problem	4	4
Material Integrity Problem	3	3
Material Frayed	3	3
Difficult to Remove	2	2
Material Fragmentation	2	2
Break	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Protective Measures Problem	1	1
Insufficient Information	1	1
Device Fell	1	1
Separation Problem	1	1
Device Markings/Labelling Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination /Decontamination Problem	1	1
Unraveled Material	1	1
Improper or Incorrect Procedure or Method	1	1
Detachment Of Device Component	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Flaked	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	13	13
Insufficient Information	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Foreign Body In Patient	5	5
Unspecified Infection	2	2
No Consequences Or Impact To Patient	2	2
No Patient Involvement	1	1
Itching Sensation	1	1
Adhesion(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ROi CPS LLC	II	Dec-28-2020
2	Steris Corporation	II	May-20-2022
3	TELEFLEX LLC	II	Dec-28-2022