TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2019	14	14
2020	10	10
2021	13	13
2022	14	14
2023	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
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
Use of Device Problem	2	2
Overheating of Device	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Temperature Problem	2	2
Unintended Electrical Shock	2	2
Excessive Heating	1	1
Insufficient Information	1	1
Noise, Audible	1	1
Material Split, Cut or Torn	1	1
Smoking	1	1
Output Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Microbial Contamination of Device	1	1
Device Displays Incorrect Message	1	1
Sparking	1	1
Output above Specifications	1	1
Nonstandard Device	1	1

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