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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anoscope and accessories
Definition To examine and perform procedures within the anus and rectum.
Product CodeFER
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4 4
2019 15 15
2020 18 18
2021 4 4
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 13 13
Unintended Movement 9 9
Detachment of Device or Device Component 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Use of Device Problem 4 4
Difficult or Delayed Positioning 3 3
Suction Problem 3 3
No Apparent Adverse Event 3 3
Activation, Positioning or Separation Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Activation Failure 2 2
Unclear Information 1 1
Defective Device 1 1
Material Perforation 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment Of Device Component 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 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 Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 9 9
No Code Available 3 3
Insufficient Information 2 2
Pain 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1
No Information 1 1
Intracranial Hemorrhage 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Nov-21-2019
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