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TPLC
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Device
tube, tympanostomy
Regulation Description
Tympanostomy tube.
Product Code
ETD
Regulation Number
874.3880
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVENTAMED DAC
SUBSTANTIALLY EQUIVALENT
1
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
2020
3
3
2021
8
8
2022
1
1
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Migration or Expulsion of Device
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Difficult to Remove
3
3
Device Dislodged or Dislocated
2
2
Malposition of Device
2
2
Device Contamination with Chemical or Other Material
1
1
Expiration Date Error
1
1
Device Fell
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
10
10
Unspecified Infection
3
3
Insufficient Information
1
1
Pleural Effusion
1
1
Failure of Implant
1
1
Injury
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Adept Medical Ltd
II
Jan-17-2025
2
Olympus Corporation of the Americas
II
Dec-19-2024
3
Olympus Corporation of the Americas
II
Feb-07-2024
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