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
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	1479	1481
Material Separation	1276	1276
No Apparent Adverse Event	753	754
Adverse Event Without Identified Device or Use Problem	628	641
Break	231	231
Product Quality Problem	176	177
Difficult to Remove	130	130
Component Missing	83	83
Material Fragmentation	20	20
Defective Component	15	15
Difficult to Insert	13	13
Sharp Edges	13	13
Unraveled Material	11	11
Patient-Device Incompatibility	8	8
Defective Device	4	5
Detachment of Device or Device Component	4	4
Lack of Effect	4	4
Material Split, Cut or Torn	3	3
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
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
Degraded	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	1763	1764
Foreign Body In Patient	1607	1609
Insufficient Information	391	391
Pain	323	324
Discomfort	249	250
Abnormal Vaginal Discharge	76	76
No Consequences Or Impact To Patient	67	67
Abdominal Pain	49	49
Abdominal Cramps	49	49
Unspecified Infection	46	46
Bacterial Infection	33	33
Nausea	33	33
Vaginal Mucosa Damage	31	31
Toxic Shock Syndrome	31	43
Cramp(s) /Muscle Spasm(s)	31	31
Fever	29	29
Burning Sensation	28	28
Itching Sensation	26	26
Menstrual Irregularities	25	25
Headache	25	25
Anxiety	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Skin Inflammation/ Irritation	21	21
Genital Bleeding	19	19
Unspecified Tissue Injury	14	14
Swelling/ Edema	14	14
Rash	14	14
Malaise	13	13
Distress	12	12
Urinary Tract Infection	12	12
Inflammation	12	12
No Known Impact Or Consequence To Patient	12	12
Fungal Infection	12	12
Emotional Changes	11	11
Diarrhea	11	11
Vomiting	11	11
Hypersensitivity/Allergic reaction	10	10
Hemorrhage/Bleeding	9	10
Fatigue	7	7
Chills	7	7
Dizziness	7	7
Intermenstrual Bleeding	7	7
Dysuria	6	6
Abdominal Distention	6	6
Erythema	6	6
Abrasion	5	5
Laceration(s)	5	5
Cervical Changes	4	4
Local Reaction	4	4
Tachycardia	4	4