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TPLC
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show TPLC since
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Device
tube, tympanostomy
Product Code
ETD
Regulation Number
874.3880
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2024
1
1
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 Contaminated During Manufacture or Shipping
2
2
Extrusion
2
2
Malposition of Device
2
2
Device Dislodged or Dislocated
2
2
Defective Component
1
1
Device Packaging Compromised
1
1
Mechanics Altered
1
1
No Apparent Adverse Event
1
1
Material Protrusion/Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Insufficient Information
1
1
Device Fell
1
1
Metal Shedding Debris
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
18
18
Foreign Body In Patient
10
10
Perforation
5
5
No Known Impact Or Consequence To Patient
5
5
Failure of Implant
2
2
Rash
2
2
Hearing Impairment
1
1
Hearing Loss
1
1
Skin Irritation
1
1
No Code Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
No Information
1
1
Local Reaction
1
1
Injury
1
1
Pleural Effusion
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Hair Loss
1
1
Pain
1
1
Scar Tissue
1
1
Bacterial Infection
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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