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TPLC
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show TPLC since
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Device
stimulator, auditory, evoked response
Product Code
GWJ
Regulation Number
882.1900
Device Class
2
Premarket Reviews
Manufacturer
Decision
FRYE ELECTRONICS, INC.
SUBSTANTIALLY EQUIVALENT
1
GN OTOMETRICS
SUBSTANTIALLY EQUIVALENT
3
GN OTOMETRICS A/S
SUBSTANTIALLY EQUIVALENT
2
GRASON STADLER
SUBSTANTIALLY EQUIVALENT
1
INTELLIGENT HEARING SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
INTERACOUSTICS A/S
SUBSTANTIALLY EQUIVALENT
2
MAICO DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
NATUS MEDICAL INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
SUBSTANTIALLY EQUIVALENT
1
PATH MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
4
R & D MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
3
3
2016
1
1
2017
43
43
2018
24
24
2019
5
5
2020
3
3
2021
3
3
2022
8
8
2023
6
6
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
53
53
Extrusion
50
50
Sparking
8
8
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Insufficient Information
4
4
Use of Device Problem
4
4
False Positive Result
4
4
Device Issue
4
4
Difficult to Remove
3
3
Component or Accessory Incompatibility
2
2
False Negative Result
2
2
Fire
2
2
Physical Resistance/Sticking
2
2
Sticking
2
2
Device Operates Differently Than Expected
2
2
Melted
2
2
Material Frayed
1
1
Signal Artifact/Noise
1
1
Device Tipped Over
1
1
Break
1
1
Split
1
1
Unintended Electrical Shock
1
1
Unable to Obtain Readings
1
1
Battery Problem
1
1
Degraded
1
1
Failure to Power Up
1
1
Structural Problem
1
1
Misassembly by Users
1
1
Data Problem
1
1
No Apparent Adverse Event
1
1
Failure to Reset
1
1
Explosion
1
1
Appropriate Term/Code Not Available
1
1
Low impedance
1
1
Device Displays Incorrect Message
1
1
Therapeutic or Diagnostic Output Failure
1
1
Smoking
1
1
Material Integrity Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
55
55
No Consequences Or Impact To Patient
49
49
No Clinical Signs, Symptoms or Conditions
20
20
Hearing Impairment
4
4
Hearing Loss
4
4
Not Applicable
3
3
Electric Shock
2
2
Skin Irritation
2
2
Pain
2
2
Hypersensitivity/Allergic reaction
1
1
Abrasion
1
1
Rash
1
1
Burn(s)
1
1
Erythema
1
1
No Patient Involvement
1
1
Skin Tears
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GN Otometrics
II
Oct-23-2019
2
Intelligent Hearing Systems Corp.
II
May-27-2010
3
Natus Medical Inc
II
Aug-03-2010
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