TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2020	10	10
2021	13	13
2022	14	14
2023	7	7
2024	5	5
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Break	5	5
Patient Device Interaction Problem	5	5
Electrical /Electronic Property Problem	4	4
Intermittent Energy Output	3	3
Energy Output Problem	3	3
Loss of or Failure to Bond	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
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
Temperature Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	14	14
No Clinical Signs, Symptoms or Conditions	8	8
Superficial (First Degree) Burn	7	7
Electric Shock	5	5
No Known Impact Or Consequence To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Shock from Patient Lead(s)	2	2
Partial thickness (Second Degree) Burn	2	2
No Consequences Or Impact To Patient	2	2
Full thickness (Third Degree) Burn	2	2
Fungal Infection	1	1
Skin Inflammation/ Irritation	1	1
Device Overstimulation of Tissue	1	1
Rash	1	1
Erythema	1	1
Swelling	1	1
Insufficient Information	1	1
Skin Tears	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	1	1