TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2018	21	21
2019	37	37
2020	51	51
2021	88	88
2022	64	64
2023	78	78

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	152	152
Device-Device Incompatibility	59	59
Crack	30	30
Naturally Worn	28	28
Material Twisted/Bent	18	18
Material Deformation	13	13
Mechanical Jam	10	10
Structural Problem	9	9
Entrapment of Device	6	6
Fracture	6	6
Scratched Material	6	6
Contamination /Decontamination Problem	6	6
Detachment of Device or Device Component	6	6
Appropriate Term/Code Not Available	5	5
Component Missing	4	4
Material Too Rigid or Stiff	4	4
Device Slipped	3	3
Difficult to Insert	3	3
Difficult to Open or Close	3	3
Material Integrity Problem	2	2
Unintended Movement	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Mechanical Problem	2	2
Fitting Problem	2	2
Failure to Align	2	2
Material Fragmentation	2	2
Material Split, Cut or Torn	2	2
Physical Resistance/Sticking	2	2
Material Frayed	1	1
Positioning Failure	1	1
Device Reprocessing Problem	1	1
Corroded	1	1
Sparking	1	1
Off-Label Use	1	1
Use of Device Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Flare or Flash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	220	220
No Consequences Or Impact To Patient	81	81
No Patient Involvement	10	10
Foreign Body In Patient	9	9
No Code Available	9	9
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Known Impact Or Consequence To Patient	3	3
No Information	2	2
Unspecified Infection	1	1
Not Applicable	1	1