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	52	52

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	131	131
Device-Device Incompatibility	58	58
Crack	28	28
Naturally Worn	25	25
Material Twisted/Bent	18	18
Material Deformation	13	13
Mechanical Jam	11	11
Structural Problem	10	10
Contamination /Decontamination Problem	6	6
Detachment of Device or Device Component	6	6
Scratched Material	5	5
Appropriate Term/Code Not Available	5	5
Entrapment of Device	5	5
Fracture	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
Material Split, Cut or Torn	2	2
Physical Resistance/Sticking	2	2
Unintended Movement	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Mechanical Problem	2	2
Fitting Problem	2	2
Material Fragmentation	2	2
Material Frayed	1	1
Positioning Failure	1	1
Device Reprocessing Problem	1	1
Corroded	1	1
Failure to Align	1	1
Sparking	1	1
Off-Label Use	1	1
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Flare or Flash	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	195	195
No Consequences Or Impact To Patient	81	81
No Patient Involvement	10	10
No Code Available	9	9
Foreign Body In Patient	8	8
Insufficient Information	7	7
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