TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
ALBAAD FEM
	SUBSTANTIALLY EQUIVALENT	1
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
COTTON HIGH TECH, SL
	SUBSTANTIALLY EQUIVALENT	1
CYCLE, LLC
	SUBSTANTIALLY EQUIVALENT	1
DONG-A PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU YOAI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ONTEX BVBA
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO YOUJIA HYGIENE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
RAEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU BORAGE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TAEBONG CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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	4468	4468
Insufficient Information	1451	1451
No Apparent Adverse Event	736	736
Adverse Event Without Identified Device or Use Problem	659	671
Break	587	587
Component Missing	352	352
Product Quality Problem	294	294
Difficult to Remove	282	282
Sharp Edges	52	52
Unraveled Material	36	36
Material Fragmentation	31	31
Defective Component	22	22
Misassembled	21	21
Material Integrity Problem	16	16
Patient-Device Incompatibility	15	15
Device Damaged Prior to Use	12	12
Difficult to Insert	12	12
Detachment of Device or Device Component	10	10
Material Disintegration	6	6
Material Split, Cut or Torn	5	5
Appropriate Term/Code Not Available	5	5
Contamination /Decontamination Problem	5	5
Lack of Effect	4	4
Entrapment of Device	3	3
Physical Resistance/Sticking	3	3
Use of Device Problem	3	3
Nonstandard Device	3	3
Defective Device	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Loose or Intermittent Connection	3	3
Separation Problem	3	3
Expulsion	3	3
Device Misassembled During Manufacturing /Shipping	2	2
Material Twisted/Bent	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Frayed	2	2
Mechanical Problem	2	2
Activation, Positioning or Separation Problem	2	2
Component Misassembled	1	1
Illegible Information	1	1
Material Protrusion/Extrusion	1	1
Device Emits Odor	1	1
Fungus in Device Environment	1	1
Mechanical Jam	1	1
Malposition of Device	1	1
Packaging Problem	1	1
Structural Problem	1	1
Unable to Obtain Readings	1	1
Degraded	1	1
Ejection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1681	1681
No Clinical Signs, Symptoms or Conditions	1589	1589
Foreign Body In Patient	1507	1507
No Known Impact Or Consequence To Patient	1269	1269
Pain	645	645
Irritation	594	594
Discomfort	372	372
Insufficient Information	369	369
Unspecified Infection	307	307
Abnormal Vaginal Discharge	235	235
Bacterial Infection	218	218
Abdominal Pain	164	164
Fungal Infection	155	155
Urinary Tract Infection	112	112
Abdominal Cramps	112	112
Fever	99	99
Itching Sensation	97	97
Device Embedded In Tissue or Plaque	94	94
Toxic Shock Syndrome	77	89
Nausea	76	76
Burning Sensation	69	69
Cramp(s)	63	63
Headache	62	62
Intermenstrual Bleeding	58	58
Menstrual Irregularities	57	57
Vomiting	44	44
Swelling	40	40
Rash	34	34
Anxiety	30	30
Chills	30	30
Inflammation	30	30
Injury	29	29
Vaginal Mucosa Damage	29	29
Diarrhea	26	26
Malaise	24	24
Distress	22	22
Cramp(s) /Muscle Spasm(s)	22	22
Dizziness	19	19
Skin Irritation	18	18
Cyst(s)	18	18
Hot Flashes/Flushes	18	18
Skin Inflammation/ Irritation	17	17
Hemorrhage/Bleeding	16	16
Genital Bleeding	14	14
Fatigue	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Emotional Changes	11	11
Sweating	10	10
Abrasion	10	10
Miscarriage	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Kimberly-Clark Corporation	II	Jan-17-2019