TPLC - Total Product Life Cycle

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Device	catheter, assisted reproduction
Product Code	MQF
Regulation Number	884.6110
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
CATHETER RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	7
CROSSBAY MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
FEMASYS INC.
	SUBSTANTIALLY EQUIVALENT	1
FERTILIGENT, LTD
	SUBSTANTIALLY EQUIVALENT	2
KITAZATO CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
KITAZATO MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDGYN PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIGIO A/S
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HORIZON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM A. COOK AUSTRALIA PTY LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination /Decontamination Problem	29	29
Device Contamination with Chemical or Other Material	22	22
Device Contaminated During Manufacture or Shipping	22	22
Material Separation	11	11
Contamination	9	9
Unsealed Device Packaging	5	5
Device Operates Differently Than Expected	3	3
Difficult to Advance	3	3
Break	3	3
Nonstandard Device	3	3
Complete Blockage	2	2
Detachment of Device or Device Component	2	2
Material Too Rigid or Stiff	2	2
Packaging Problem	2	2
Appropriate Term/Code Not Available	1	1
Infusion or Flow Problem	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Defective Component	1	1
Bent	1	1
Deflation Problem	1	1
Entrapment of Device	1	1
Fluid/Blood Leak	1	1
Material Fragmentation	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	36	36
No Clinical Signs, Symptoms or Conditions	33	33
No Patient Involvement	25	25
No Known Impact Or Consequence To Patient	9	9
Foreign Body In Patient	6	6
Device Embedded In Tissue or Plaque	3	3
No Information	2	2
Insufficient Information	2	2
Blood Loss	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Tissue Injury	1	1
Nonresorbable materials, unretrieved in body	1	1
Foreign body, removal of	1	1
Hemorrhage/Bleeding	1	1
Perforation	1	1