TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	87	87
Dull, Blunt	18	18
Fracture	12	12
Insufficient Information	11	11
Material Integrity Problem	10	10
Manufacturing, Packaging or Shipping Problem	6	6
Failure to Cut	6	6
Tear, Rip or Hole in Device Packaging	6	6
Unsealed Device Packaging	5	5
Packaging Problem	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Difficult to Remove	3	3
Product Quality Problem	3	3
Detachment of Device or Device Component	3	3
Difficult to Open or Close	3	3
Entrapment of Device	2	2
Difficult to Open or Remove Packaging Material	2	2
Degraded	2	2
Delivered as Unsterile Product	2	2
Device Handling Problem	2	2
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Device Contamination with Body Fluid	1	1
Defective Component	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Material Discolored	1	1
Material Too Rigid or Stiff	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Material Separation	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Material Too Soft/Flexible	1	1
Extra Components	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	87	87
Foreign Body In Patient	32	32
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	16	16
No Consequences Or Impact To Patient	15	15
Laceration(s)	6	6
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
No Patient Involvement	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1
Nervous System Injury	1	1

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