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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, tympanostomy
Product CodeETD
Regulation Number 874.3880
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVENTAMED DAC
  SUBSTANTIALLY EQUIVALENT 1
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GRACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECEPTIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PRECEPTIS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PRECEPTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TUSKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4
2016 2 2
2017 7 7
2018 2 2
2019 18 18
2020 3 3
2021 8 8
2022 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Migration or Expulsion of Device 4 4
Difficult to Remove 3 3
Device Dislodged or Dislocated 2 2
Extrusion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
Device Contamination with Chemical or Other Material 1 1
Metal Shedding Debris 1 1
Defective Component 1 1
Malposition of Device 1 1
Device Packaging Compromised 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 18 18
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 5 5
Perforation 5 5
Rash 2 2
Failure of Implant 2 2
Local Reaction 1 1
Scar Tissue 1 1
Skin Irritation 1 1
Injury 1 1
No Patient Involvement 1 1
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Pleural Effusion 1 1
Pain 1 1
Bacterial Infection 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Hearing Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus ACMI Corporation I Mar-04-2010
2 Gyrus Acmi, Incorporated II Nov-20-2012
3 Micromedics, Inc. I Nov-18-2010
4 Olympus Corporation of the Americas II Feb-07-2024
5 Summit Medical, Inc. II Jun-09-2014
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