TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ANNES DAYE LTD
	SUBSTANTIALLY EQUIVALENT	1
CALLA LILY PERSONAL CARE, LTD.
	SUBSTANTIALLY EQUIVALENT	3
COTTON HIGH TECH S.L.
	SUBSTANTIALLY EQUIVALENT	2
COTTON HIGH TECH, S.L.
	SUBSTANTIALLY EQUIVALENT	1
CYCLE, LLC
	SUBSTANTIALLY EQUIVALENT	1
DONG-A PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ESSITY HIGIENE Y SALUD MEXICO. S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO YOUJIA HYGIENE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG INTCO HYGIENE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU BORAGE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TAMPRO INC
	SUBSTANTIALLY EQUIVALENT	1
TOSAMA, D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
UNIBEAUTY (HUBEI) TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG TIANQING MANUFACTURING TECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	1868	1868
Insufficient Information	1587	1587
No Apparent Adverse Event	861	861
Adverse Event Without Identified Device or Use Problem	684	696
Break	400	400
Component Missing	309	309
Product Quality Problem	276	276
Difficult to Remove	241	241
Sharp Edges	37	37
Material Fragmentation	28	28
Defective Component	19	19
Unraveled Material	18	18
Difficult to Insert	12	12
Patient-Device Incompatibility	11	11
Detachment of Device or Device Component	6	6
Appropriate Term/Code Not Available	4	4
Misassembled	4	4
Lack of Effect	4	4
Defective Device	4	4
Contamination	3	3
Contamination /Decontamination Problem	3	3
Material Disintegration	3	3
Use of Device Problem	3	3
Material Split, Cut or Torn	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Device Damaged Prior to Use	2	2
Material Twisted/Bent	2	2
Physical Resistance/Sticking	2	2
Mechanical Problem	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Expulsion	2	2
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Ejection Problem	1	1
Collapse	1	1
Degraded	1	1
Unable to Obtain Readings	1	1
Structural Problem	1	1
Packaging Problem	1	1
Activation, Positioning or Separation Problem	1	1
Material Frayed	1	1
Device Emits Odor	1	1
Material Protrusion/Extrusion	1	1
Nonstandard Device	1	1
Fungus in Device Environment	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1738	1738
Foreign Body In Patient	1661	1661
No Consequences Or Impact To Patient	938	938
Insufficient Information	377	377
Pain	375	375
No Known Impact Or Consequence To Patient	351	351
Discomfort	274	274
Abnormal Vaginal Discharge	82	82
Device Embedded In Tissue or Plaque	80	80
Abdominal Pain	64	64
Abdominal Cramps	60	60
Unspecified Infection	49	49
Bacterial Infection	40	40
Fever	37	37
Burning Sensation	36	36
Itching Sensation	36	36
Toxic Shock Syndrome	34	46
Nausea	33	33
Vaginal Mucosa Damage	32	32
Headache	29	29
Cramp(s) /Muscle Spasm(s)	25	25
Menstrual Irregularities	24	24
Anxiety	23	23
Fungal Infection	20	20
Malaise	19	19
Skin Inflammation/ Irritation	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Diarrhea	17	17
Cramp(s)	16	16
Intermenstrual Bleeding	16	16
Genital Bleeding	15	15
Vomiting	14	14
Urinary Tract Infection	14	14
Distress	13	13
Hemorrhage/Bleeding	12	12
Rash	12	12
Emotional Changes	11	11
Swelling/ Edema	11	11
Irritation	11	11
Inflammation	11	11
Chills	11	11
Unspecified Tissue Injury	9	9
Hypersensitivity/Allergic reaction	9	9
Fatigue	7	7
Dysuria	6	6
Dizziness	6	6
Swelling	6	6
Abrasion	6	6
Hot Flashes/Flushes	5	5
Abdominal Distention	5	5