TPLC - Total Product Life Cycle

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Device	stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Regulation Description	Ultrasound and muscle stimulator.
Product Code	IMG
Regulation Number	890.5860
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21	21
Break	7	7
Intermittent Energy Output	6	6
Electrical /Electronic Property Problem	5	5
Loss of or Failure to Bond	4	4
Energy Output Problem	3	3
Patient Device Interaction Problem	3	3
Unintended Electrical Shock	2	2
Insufficient Information	2	2
Use of Device Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Overheating of Device	2	2
Temperature Problem	2	2
Sparking	1	1
Material Split, Cut or Torn	1	1
Output Problem	1	1
Smoking	1	1
Output above Specifications	1	1
Microbial Contamination of Device	1	1
No Apparent Adverse Event	1	1
Excessive Heating	1	1
Nonstandard Device	1	1
Improper or Incorrect Procedure or Method	1	1
Device Displays Incorrect Message	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	12	12
No Clinical Signs, Symptoms or Conditions	8	8
Superficial (First Degree) Burn	7	7
Electric Shock	6	6
No Known Impact Or Consequence To Patient	6	6
No Consequences Or Impact To Patient	6	6
Partial thickness (Second Degree) Burn	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Full thickness (Third Degree) Burn	3	3
Shock from Patient Lead(s)	2	2
Patient Problem/Medical Problem	1	1
Fungal Infection	1	1
No Code Available	1	1
Skin Inflammation/ Irritation	1	1
Scarring	1	1
Device Overstimulation of Tissue	1	1
Rash	1	1
Erythema	1	1
Swelling	1	1
No Patient Involvement	1	1
Insufficient Information	1	1
Skin Tears	1	1
Lead(s), Burn(s) From	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	1	1