TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	575	575
Device-Device Incompatibility	83	83
Material Integrity Problem	80	80
Mechanical Problem	19	19
Material Twisted/Bent	15	15
Material Deformation	13	13
Material Fragmentation	12	12
Use of Device Problem	12	12
Compatibility Problem	10	10
Contamination /Decontamination Problem	9	9
Crack	7	7
Fracture	7	7
No Apparent Adverse Event	6	6
Entrapment of Device	5	5
Difficult to Open or Close	5	5
Mechanical Jam	5	5
Device Slipped	4	4
Physical Resistance/Sticking	4	4
Insufficient Information	4	4
Appropriate Term/Code Not Available	4	4
Corroded	4	4
Product Quality Problem	3	3
Detachment of Device or Device Component	3	3
Degraded	2	2
Component Missing	2	2
Output Problem	1	1
Failure to Clean Adequately	1	1
Failure to Align	1	1
Failure to Cut	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Sharp Edges	1	1
Residue After Decontamination	1	1
Grounding Malfunction	1	1
Nonstandard Device	1	1
Unexpected Therapeutic Results	1	1
Human-Device Interface Problem	1	1
Electrical /Electronic Property Problem	1	1
Dull, Blunt	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	572	572
No Consequences Or Impact To Patient	141	141
No Patient Involvement	76	76
Insufficient Information	24	24
No Known Impact Or Consequence To Patient	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
Not Applicable	1	1
Vascular Dissection	1	1
Perforation	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	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