TPLC - Total Product Life Cycle

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Device	catheter, assisted reproduction
Regulation Description	Assisted reproduction catheters.
Product Code	MQF
Regulation Number	884.6110
Device Class	2

Premarket Reviews
Manufacturer	Decision
FEMASYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU HEHONG BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HORIZON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VITROLIFE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contaminated During Manufacture or Shipping	37	37
Contamination	14	14
Unsealed Device Packaging	5	5
Contamination /Decontamination Problem	5	5
Complete Blockage	3	3
Packaging Problem	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
Nonstandard Device	2	2
Break	1	1
Entrapment of Device	1	1
Mechanical Problem	1	1
Difficult to Advance	1	1
Defective Component	1	1
Difficult to Remove	1	1
Material Fragmentation	1	1
Obstruction of Flow	1	1
Infusion or Flow Problem	1	1
Material Deformation	1	1
Device Contamination with Chemical or Other Material	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	62	62
Foreign Body In Patient	6	6
Insufficient Information	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	1	1
Unspecified Tissue Injury	1	1