TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHURCH & DWIGHT CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
LELO, INC.
	SUBSTANTIALLY EQUIVALENT	1
OKAMOTO USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
RB HEALTH (US), LLC
	SUBSTANTIALLY EQUIVALENT	4
SHANGHAI PERSONAGE HYGIENE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHAOGUAN REGENEX PHARMACEUTICALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SURETEX LIMITED
	SUBSTANTIALLY EQUIVALENT	3
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED.
	SUBSTANTIALLY EQUIVALENT	2
TITAN CONDOMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
TTK HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	31	31
Adverse Event Without Identified Device or Use Problem	9	9
Defective Device	6	6
Therapeutic or Diagnostic Output Failure	6	6
Device Slipped	4	4
Patient-Device Incompatibility	3	3
Defective Component	2	2
Material Fragmentation	2	2
Inadequacy of Device Shape and/or Size	2	2
Material Split, Cut or Torn	1	1
Entrapment of Device	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Patient Device Interaction Problem	1	1
Fail-Safe Problem	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Material Rupture	1	1
Device Emits Odor	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Sexually Transmitted Infection	30	30
No Clinical Signs, Symptoms or Conditions	11	11
Insufficient Information	11	11
Rash	6	6
Hypersensitivity/Allergic reaction	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Viral Infection	3	3
Unspecified Infection	2	2
Pregnancy with a Contraceptive Device	2	2
Pain	2	2
Urinary Tract Infection	2	2
Abdominal Pain	1	1
Fungal Infection	1	1
Dysuria	1	1
Dizziness	1	1
Hematuria	1	1
Burn(s)	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Exposure to Body Fluids	1	1
Discomfort	1	1
HIV, Human Immunodeficiency Virus	1	1
Choking	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Immunodeficiency	1	1
Caustic/Chemical Burns	1	1
Bacterial Infection	1	1