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TPLC
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show TPLC since
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Device
protector, skin pressure
Product Code
FMP
Regulation Number
880.6450
Device Class
1
Premarket Reviews
Manufacturer
Decision
INVICTUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
26
26
2015
9
9
2016
11
11
2017
2
2
2018
1
1
2019
5
5
2020
3
3
2021
4
4
2022
60
60
2023
15
15
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Deflation Problem
40
40
Unintended Deflation
29
29
Insufficient Information
17
17
Adverse Event Without Identified Device or Use Problem
12
12
Device Contamination with Chemical or Other Material
9
9
Material Integrity Problem
5
5
Patient-Device Incompatibility
3
3
Appropriate Term/Code Not Available
3
3
Fitting Problem
2
2
Contamination
2
2
Material Discolored
2
2
Nonstandard Device
2
2
Improper or Incorrect Procedure or Method
2
2
Product Quality Problem
2
2
Device Contaminated During Manufacture or Shipping
1
1
Signal Artifact/Noise
1
1
Leak/Splash
1
1
Device Slipped
1
1
Patient Device Interaction Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Moisture Damage
1
1
Positioning Failure
1
1
Inadequate or Insufficient Training
1
1
Human-Device Interface Problem
1
1
Burst Container or Vessel
1
1
Off-Label Use
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Inflation Problem
1
1
Packaging Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
51
51
Insufficient Information
29
29
Pressure Sores
18
18
No Known Impact Or Consequence To Patient
10
10
No Consequences Or Impact To Patient
8
8
Skin Erosion
4
4
Injury
3
3
No Patient Involvement
3
3
Fall
3
3
Tissue Damage
3
3
Tissue Breakdown
3
3
Death
2
2
Obstruction/Occlusion
2
2
Confusion/ Disorientation
2
2
Intracranial Hemorrhage
2
2
Laceration(s)
2
2
Ulcer
2
2
Fungal Infection
1
1
Necrosis
1
1
No Information
1
1
Blister
1
1
Skin Discoloration
1
1
Weakness
1
1
Erythema
1
1
Pain
1
1
Scar Tissue
1
1
Abscess
1
1
Ulceration
1
1
Skin Tears
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Jan-06-2016
2
Childrens Medical Ventures
I
Aug-20-2014
3
EHOB, Inc.
II
Jul-20-2020
4
Philips Medical Systems, Inc.
I
Dec-16-2014
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