TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	86	86
Dull, Blunt	18	18
Fracture	12	12
Material Integrity Problem	10	10
Failure to Cut	6	6
Tear, Rip or Hole in Device Packaging	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Packaging Problem	5	5
Unsealed Device Packaging	5	5
Insufficient Information	4	4
Product Quality Problem	3	3
Difficult to Remove	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Detachment of Device or Device Component	3	3
Difficult to Open or Close	3	3
Difficult to Open or Remove Packaging Material	2	2
Device Handling Problem	2	2
Degraded	2	2
Entrapment of Device	2	2
Delivered as Unsterile Product	2	2
Structural Problem	1	1
Material Discolored	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Material Too Rigid or Stiff	1	1
Material Separation	1	1
Use of Device Problem	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1
Material Too Soft/Flexible	1	1
Material Split, Cut or Torn	1	1
Extra Components	1	1
No Apparent Adverse Event	1	1
Device Contamination with Chemical or Other Material	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	77
Foreign Body In Patient	32	32
No Known Impact Or Consequence To Patient	22	22
No Consequences Or Impact To Patient	15	15
Insufficient Information	14	14
Laceration(s)	6	6
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
No Patient Involvement	3	3
Tissue Damage	1	1
Nervous System Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Southmedic, Inc.	II	Nov-23-2022