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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
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GRACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECEPTIS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PRECEPTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 18 18
Migration or Expulsion of Device 4 4
Difficult to Remove 3 3
Device Dislodged or Dislocated 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Device Contamination with Chemical or Other Material 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 17 17
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Pleural Effusion 1 1
Injury 1 1
Failure of Implant 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-07-2024
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