TPLC - Total Product Life Cycle

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Device	aid, transfer
Regulation Description	Daily activity assist device.
Product Code	IKX
Regulation Number	890.5050
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	45	45
Break	10	10
Insufficient Information	7	7
Mechanical Problem	7	7
Patient-Device Incompatibility	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Entrapment of Device	2	2
Off-Label Use	1	1
Collapse	1	1
Device Handling Problem	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Crack	1	1
Material Integrity Problem	1	1
Device Fell	1	1
Patient Device Interaction Problem	1	1
Human-Device Interface Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
Fall	7	7
Physical Entrapment	4	4
Insufficient Information	4	4
Laceration(s)	3	3
Pain	3	3
Strangulation	3	3
Abrasion	3	3
Bone Fracture(s)	3	3
Death	2	2
Concussion	1	1
No Consequences Or Impact To Patient	1	1
No Known Impact Or Consequence To Patient	1	1
Joint Dislocation	1	1
Bruise/Contusion	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Unspecified Musculoskeletal problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1