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TPLC
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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
Torn Material
2
2
Device Inoperable
2
2
Fluid/Blood Leak
2
2
Naturally Worn
2
2
Leak/Splash
2
2
Insufficient Information
1
1
Inflation Problem
1
1
Material Rupture
1
1
Overheating of Device
1
1
Device Emits Odor
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Device-Device Incompatibility
1
1
Inadequate Instructions for Healthcare Professional
1
1
Contamination
1
1
Air Leak
1
1
Delamination
1
1
Material Discolored
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Sharp Edges
1
1
Decrease in Pressure
1
1
Device Operates Differently Than Expected
1
1
Improper or Incorrect Procedure or Method
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
No Information
3
3
Fall
3
3
No Code Available
1
1
Discomfort
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Pain
1
1
Pressure Sores
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
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