TPLC - Total Product Life Cycle

show TPLC since

Device	indicator, biological sterilization process
Product Code	FRC
Regulation Number	880.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M
	SUBSTANTIALLY EQUIVALENT	1
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	11
3M COMPLANY
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED STERILIZATION PRODUCTS (ASP)
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
PLASMAPP CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERILUCENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	3
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	1
TSO3 INC., NOW A PART OF STRYKER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	77	77
Leak/Splash	6	6
Chemical Problem	5	5
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Break	1	1
Off-Label Use	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Component Missing	1	1
Problem with Sterilization	1	1
No Apparent Adverse Event	1	1
Device Reprocessing Problem	1	1
Improper Chemical Reaction	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	48	48
No Known Impact Or Consequence To Patient	29	29
No Consequences Or Impact To Patient	18	18
Burn(s)	3	3
Insufficient Information	2	2
Patient Problem/Medical Problem	1	1
Skin Discoloration	1	1
Discomfort	1	1
Laceration(s)	1	1
Eye Injury	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Sep-26-2023
2	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
3	Steris Corporation	II	Jan-03-2023
4	TERRAGENE S.A.	II	Jan-26-2024