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TPLC
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Device
anoscope and accessories
Definition
To examine and perform procedures within the anus and rectum.
Product Code
FER
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
APPLIED MEDICAL RESOURCES
SUBSTANTIALLY EQUIVALENT
1
APPLIED MEDICAL RESOURCES CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
4
4
2018
4
4
2019
15
15
2020
18
18
2021
4
4
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
13
13
Unintended Movement
8
8
Detachment of Device or Device Component
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Detachment Of Device Component
4
4
Use of Device Problem
4
4
Suction Problem
3
3
Difficult or Delayed Positioning
3
3
No Apparent Adverse Event
3
3
Activation Failure
2
2
Activation, Positioning or SeparationProblem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Defective Device
1
1
Biocompatibility
1
1
Contamination /Decontamination Problem
1
1
Break
1
1
Material Fragmentation
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Perforation
1
1
Improper or Incorrect Procedure or Method
1
1
Unclear Information
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
21
21
No Consequences Or Impact To Patient
13
13
No Clinical Signs, Symptoms or Conditions
12
12
No Code Available
3
3
Insufficient Information
2
2
Skin Tears
1
1
Blood Loss
1
1
No Patient Involvement
1
1
No Information
1
1
Hemorrhage/Bleeding
1
1
Intracranial Hemorrhage
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
II
Nov-21-2019
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