TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	525	525
Material Integrity Problem	74	74
Device-Device Incompatibility	72	72
Mechanical Problem	19	19
Material Twisted/Bent	15	15
Material Deformation	12	12
Use of Device Problem	11	11
Compatibility Problem	10	10
Contamination /Decontamination Problem	8	8
Fracture	7	7
Crack	7	7
Material Fragmentation	5	5
Entrapment of Device	5	5
Difficult to Open or Close	5	5
Mechanical Jam	5	5
No Apparent Adverse Event	5	5
Insufficient Information	4	4
Appropriate Term/Code Not Available	4	4
Physical Resistance/Sticking	4	4
Corroded	4	4
Device Slipped	3	3
Detachment of Device or Device Component	2	2
Component Missing	2	2
Degraded	2	2
Product Quality Problem	2	2
Grounding Malfunction	1	1
Electrical /Electronic Property Problem	1	1
Residue After Decontamination	1	1
Dull, Blunt	1	1
Failure to Align	1	1
Failure to Cut	1	1
Unexpected Therapeutic Results	1	1
Sharp Edges	1	1
Failure to Clean Adequately	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	501	501
No Consequences Or Impact To Patient	141	141
No Patient Involvement	76	76
No Known Impact Or Consequence To Patient	14	14
Insufficient Information	14	14
No Code Available	8	8
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Patient Problem/Medical Problem	2	2
Burn(s)	2	2
Hemorrhage/Bleeding	1	1
Perforation	1	1
Tissue Damage	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Vascular Dissection	1	1
Device Embedded In Tissue or Plaque	1	1
Not Applicable	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConvaTec, Inc	II	Mar-21-2019
2	Stradis Medical, LLC dba Stradis Healthcare	II	Aug-18-2022