TPLC - Total Product Life Cycle

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Device	tampon, menstrual, unscented
Regulation Description	Unscented menstrual tampon.
Definition	An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Product Code	HEB
Regulation Number	884.5470
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANNES DAYE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CALLA LILY PERSONAL CARE, LTD.
	SUBSTANTIALLY EQUIVALENT	2
COTTON HIGH TECH S.L.
	SUBSTANTIALLY EQUIVALENT	4
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
LIVIWELL, INC.
	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	4
ZHEJIANG TIANQING MANUFACTURING TECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1530	1532
Material Separation	1281	1281
No Apparent Adverse Event	769	770
Adverse Event Without Identified Device or Use Problem	644	657
Break	236	236
Product Quality Problem	180	181
Difficult to Remove	130	130
Component Missing	86	86
Material Fragmentation	20	20
Defective Component	15	15
Difficult to Insert	13	13
Sharp Edges	13	13
Unraveled Material	11	11
Patient-Device Incompatibility	9	9
Material Split, Cut or Torn	4	4
Defective Device	4	5
Detachment of Device or Device Component	4	4
Lack of Effect	4	4
Physical Resistance/Sticking	3	3
Contamination	3	3
Use of Device Problem	3	3
Appropriate Term/Code Not Available	2	2
Separation Problem	2	2
Mechanical Problem	2	2
Device Damaged Prior to Use	2	2
Material Disintegration	2	2
Device Emits Odor	2	2
Degraded	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Loose or Intermittent Connection	1	1
Material Protrusion/Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1
Packaging Problem	1	1
Misassembled	1	1
Unable to Obtain Readings	1	1
Ejection Problem	1	1
Contamination /Decontamination Problem	1	1
Microbial Contamination of Device	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unsealed Device Packaging	1	1
Entrapment of Device	1	1
Device Contaminated During Manufacture or Shipping	1	1
Activation, Positioning or Separation Problem	1	1
Material Frayed	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1788	1789
Foreign Body In Patient	1658	1660
Insufficient Information	393	393
Pain	331	332
Discomfort	254	255
Abnormal Vaginal Discharge	81	81
No Consequences Or Impact To Patient	67	67
Abdominal Pain	53	53
Abdominal Cramps	49	49
Unspecified Infection	48	48
Nausea	36	36
Bacterial Infection	35	35
Cramp(s) /Muscle Spasm(s)	34	34
Toxic Shock Syndrome	31	43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	31	31
Vaginal Mucosa Damage	31	31
Burning Sensation	29	29
Fever	29	29
Itching Sensation	28	28
Menstrual Irregularities	26	26
Headache	25	25
Anxiety	24	24
Skin Inflammation/ Irritation	21	21
Genital Bleeding	19	19
Unspecified Tissue Injury	17	17
Swelling/ Edema	15	15
Malaise	15	15
Rash	14	14
Fungal Infection	13	13
No Known Impact Or Consequence To Patient	12	12
Inflammation	12	12
Distress	12	12
Urinary Tract Infection	12	12
Emotional Changes	11	11
Vomiting	11	11
Diarrhea	11	11
Hypersensitivity/Allergic reaction	10	10
Hemorrhage/Bleeding	9	10
Dizziness	8	8
Chills	7	7
Erythema	7	7
Intermenstrual Bleeding	7	7
Fatigue	7	7
Abdominal Distention	6	6
Dysuria	6	6
Local Reaction	5	5
Abrasion	5	5
Laceration(s)	5	5
Loss of consciousness	4	4
Hematuria	4	4