TPLC - Total Product Life Cycle

• Device: pad, heating, powered
• Product Code: IRT
• Regulation Number: 890.5740
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2017	220	220
2018	325	325
2019	205	205
2020	117	117
2021	97	97
2022	24	25

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper or Incorrect Procedure or Method	218	218
Fire	204	204
Adverse Event Without Identified Device or Use Problem	188	189
Sparking	128	128
Thermal Decomposition of Device	104	104
Smoking	75	75
Break	56	56
Overheating of Device	55	55
Use of Device Problem	55	55
Device Emits Odor	50	50
Insufficient Information	31	31
Material Twisted/Bent	28	28
Bent	27	27
Melted	26	26
Material Discolored	20	20
Material Split, Cut or Torn	20	20
Cut In Material	19	19
Failure to Shut Off	18	18
Crack	18	18
Temperature Problem	18	18
Noise, Audible	16	16
Device Operates Differently Than Expected	15	15
Excessive Heating	13	13
Patient-Device Incompatibility	12	12
Electrical /Electronic Property Problem	9	9
Electrical Shorting	8	8
Naturally Worn	8	8
Material Puncture/Hole	7	7
Inappropriate/Inadequate Shock/Stimulation	7	7
Hole In Material	6	6
Flare or Flash	6	6
Unexpected Therapeutic Results	5	5
Device Inoperable	5	5
Material Protrusion/Extrusion	4	4
Insufficient Heating	4	4
Appropriate Term/Code Not Available	4	4
Patient Device Interaction Problem	3	3
Detachment Of Device Component	3	3
Burst Container or Vessel	3	3
Loss of Power	3	3
Failure to Power Up	3	3
Self-Activation or Keying	3	3
Material Deformation	3	3
Structural Problem	3	3
Folded	3	3
Deformation Due to Compressive Stress	2	2
Split	2	2
Defective Component	2	2
Component Missing	2	2
Detachment of Device or Device Component	2	2
Material Separation	2	2
Device Stops Intermittently	2	2
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Fluid Leak	2	2
Therapeutic or Diagnostic Output Failure	2	2
Torn Material	1	1
Unintended Electrical Shock	1	1
Entrapment of Device	1	1
Circuit Failure	1	1
Contamination	1	1
No Display/Image	1	1
Peeled/Delaminated	1	1
Product Quality Problem	1	1
Device Remains Activated	1	1
Material Rupture	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanics Altered	1	1
Output Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Scratched Material	1	1
Arcing	1	1
Failure to Cut	1	1
Failure to Advance	1	1
Connection Problem	1	1
Device Packaging Compromised	1	1
Device Unsafe to Use in Environment	1	1
Device-Device Incompatibility	1	1
Device Dislodged or Dislocated	1	1
Electrical Power Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	330	331
No Known Impact Or Consequence To Patient	290	290
No Consequences Or Impact To Patient	148	148
Burn, Thermal	56	56
No Information	36	36
Partial thickness (Second Degree) Burn	34	34
No Clinical Signs, Symptoms or Conditions	27	27
Full thickness (Third Degree) Burn	18	18
Insufficient Information	14	14
Electric Shock	12	12
Superficial (First Degree) Burn	11	11
Injury	8	8
No Code Available	3	3
Pain	3	3
Shock	3	3
Death	3	3
Unspecified Infection	3	3
Nerve Damage	2	2
Burning Sensation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Blister	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Respiratory Acidosis	1	1
Sleep Dysfunction	1	1
Alteration In Body Temperature	1	1
Shock from Patient Lead(s)	1	1
Not Applicable	1	1
Tingling	1	1
Discomfort	1	1
Swelling	1	1
Peeling	1	1
Scarring	1	1
Bruise/Contusion	1	1
Irritation	1	1
Laceration(s)	1	1
Dry Eye(s)	1	1
Electrocution	1	1
Erythema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	2k Innovations Inc.	II	Apr-12-2017