TPLC - Total Product Life Cycle

• Device: instrument, compression
• Product Code: HWN
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	37	37
2020	51	51
2021	88	88
2022	64	64
2023	83	83
2024	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	157	157
Device-Device Incompatibility	69	69
Naturally Worn	35	35
Crack	31	31
Material Deformation	20	20
Material Twisted/Bent	18	18
Structural Problem	10	10
Mechanical Jam	9	9
Scratched Material	9	9
Contamination /Decontamination Problem	8	8
Detachment of Device or Device Component	7	7
Fracture	7	7
Entrapment of Device	6	6
Material Too Rigid or Stiff	4	4
Appropriate Term/Code Not Available	4	4
Difficult to Open or Close	3	3
Device Slipped	3	3
Component Missing	3	3
Difficult to Insert	3	3
Mechanical Problem	2	2
Material Fragmentation	2	2
Failure to Align	2	2
Material Integrity Problem	2	2
Physical Resistance/Sticking	2	2
Unintended Movement	2	2
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Split, Cut or Torn	1	1
Device Dislodged or Dislocated	1	1
Connection Problem	1	1
Use of Device Problem	1	1
Fitting Problem	1	1
Material Frayed	1	1
Off-Label Use	1	1
Positioning Failure	1	1
Device Reprocessing Problem	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	243	243
No Consequences Or Impact To Patient	69	69
Insufficient Information	13	13
Foreign Body In Patient	10	10
No Code Available	8	8
No Patient Involvement	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Known Impact Or Consequence To Patient	2	2