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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
GRASON STADLER
SUBSTANTIALLY EQUIVALENT
1
INTELLIGENT HEARING SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
INTERACOUSTICS A/S
SUBSTANTIALLY EQUIVALENT
1
PATH MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
43
43
2018
24
24
2019
5
5
2020
3
3
2021
3
3
2022
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
53
53
Extrusion
50
50
Use of Device Problem
4
4
Device Issue
4
4
False Positive Result
4
4
Difficult to Remove
3
3
Incorrect, Inadequate or Imprecise Resultor Readings
3
3
Sparking
3
3
Physical Resistance/Sticking
2
2
Sticking
2
2
Fire
2
2
Material Frayed
1
1
Melted
1
1
Failure to Power Up
1
1
Signal Artifact/Noise
1
1
Break
1
1
Degraded
1
1
False Negative Result
1
1
Smoking
1
1
Structural Problem
1
1
Split
1
1
Device Tipped Over
1
1
Unintended Electrical Shock
1
1
Battery Problem
1
1
Low impedance
1
1
Therapeutic or Diagnostic Output Failure
1
1
Misassembly by Users
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Explosion
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
48
48
No Clinical Signs, Symptoms or Conditions
9
9
Hearing Loss
4
4
Not Applicable
3
3
Skin Irritation
2
2
Electric Shock
2
2
No Patient Involvement
1
1
Skin Tears
1
1
Pain
1
1
Abrasion
1
1
Erythema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GN Otometrics
II
Oct-23-2019
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