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	39	39

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	165	165
Device-Device Incompatibility	70	70
Naturally Worn	36	36
Crack	33	33
Material Deformation	24	24
Material Twisted/Bent	19	19
Scratched Material	10	10
Structural Problem	10	10
Contamination /Decontamination Problem	9	9
Mechanical Jam	9	9
Entrapment of Device	8	8
Detachment of Device or Device Component	8	8
Fracture	7	7
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
Difficult to Insert	3	3
Component Missing	3	3
Corroded	2	2
Mechanical Problem	2	2
Material Fragmentation	2	2
Material Integrity Problem	2	2
Failure to Align	2	2
Unintended Movement	2	2
Physical Resistance/Sticking	2	2
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Material Split, Cut or Torn	1	1
Therapeutic or Diagnostic Output Failure	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Material Frayed	1	1
Positioning Failure	1	1
Device Reprocessing Problem	1	1
Off-Label Use	1	1
Use of Device Problem	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	257	257
No Consequences Or Impact To Patient	69	69
Insufficient Information	16	16
Foreign Body In Patient	12	12
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