TPLC - Total Product Life Cycle

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Device	hearing aid, air-conduction, prescription
Definition	An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Product Code	ESD
Regulation Number	874.3300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Noise, Audible	11	11
Therapeutic or Diagnostic Output Failure	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device Dislodged or Dislocated	5	5
Patient-Device Incompatibility	5	5
Defective Device	5	5
Device Operates Differently Than Expected	5	5
Break	5	5
Patient Device Interaction Problem	5	5
Insufficient Information	4	4
Detachment Of Device Component	4	4
Use of Device Problem	3	3
Product Quality Problem	3	3
Difficult to Remove	2	2
Inadequate Instructions for Non-Healthcare Professional	2	2
Device Inoperable	2	2
Physical Resistance/Sticking	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Moisture or Humidity Problem	1	1
Output Problem	1	1
Electrical Shorting	1	1
Electromagnetic Compatibility Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device-Device Incompatibility	1	1
Device Or Device Fragments Location Unknown	1	1
Application Program Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Inadequacy of Device Shape and/or Size	1	1
Improper or Incorrect Procedure or Method	1	1
Burst Container or Vessel	1	1
Material Fragmentation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Device Emits Odor	1	1
Overheating of Device	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hearing Impairment	8	8
No Clinical Signs, Symptoms or Conditions	8	8
Pain	7	7
Hearing Loss	6	6
No Known Impact Or Consequence To Patient	6	6
Foreign Body In Patient	5	5
Unspecified Infection	5	5
No Information	4	4
Discomfort	3	3
Skin Inflammation	2	2
Therapeutic Response, Decreased	2	2
No Code Available	2	2
Partial Hearing Loss	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Headache	2	2
Erosion	1	1
Burn(s)	1	1
Fall	1	1
Hemorrhage/Bleeding	1	1
Failure of Implant	1	1
Perforation	1	1
Shock	1	1
Tinnitus	1	1
Tissue Damage	1	1
Twitching	1	1
Discharge	1	1
Viral Infection	1	1
Unspecified Ear or Labyrinth Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Not Applicable	1	1
Burn, Thermal	1	1
Electric Shock	1	1
Complaint, Ill-Defined	1	1
Impaired Healing	1	1