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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device audiometer
Product CodeEWO
Regulation Number 874.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
HEARX SA (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
OTODYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 7 7
2021 3 3
2022 6 6
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Melted 6 6
Break 4 4
Battery Problem 4 4
Component Incompatible 3 3
Unintended Electrical Shock 3 3
Overheating of Device 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Charging Problem 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Electro-Static Discharge 1 1
Device Displays Incorrect Message 1 1
Crack 1 1
Degraded 1 1
Electrical /Electronic Property Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Not Applicable 5 5
Insufficient Information 2 2
Abrasion 2 2
Electric Shock 2 2
No Known Impact Or Consequence To Patient 1 1
Headache 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PATH II Nov-25-2023
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