TPLC - Total Product Life Cycle

• Device: cover, mattress (medical purposes)
• Product Code: FMW
• Regulation Number: 880.6190
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
PRECISION FABRICS GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	22	22
2015	1	1
2017	3	3
2018	1	1
2019	4	4
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Moisture Damage	6	6
Break	3	3
Material Integrity Problem	3	3
Naturally Worn	2	2
Leak/Splash	2	2
Device Inoperable	2	2
Fluid/Blood Leak	2	2
Torn Material	2	2
Insufficient Information	1	1
Sharp Edges	1	1
Inflation Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Contamination	1	1
Material Discolored	1	1
Device Emits Odor	1	1
Overheating of Device	1	1
Decrease in Pressure	1	1
Material Rupture	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Improper or Incorrect Procedure or Method	1	1
Delamination	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Air Leak	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	15	15
No Consequences Or Impact To Patient	7	7
Fall	3	3
No Information	3	3
No Code Available	1	1
Insufficient Information	1	1
Laceration(s)	1	1
Pain	1	1
Pressure Sores	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Invacare Corporation	II	Sep-12-2010
2	Invacare Corporation	II	Sep-12-2010
3	Primus Medical LLC	II	Sep-09-2014