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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tampon, menstrual, unscented
Regulation Description Unscented menstrual tampon.
Product CodeHEB
Regulation Number 884.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
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

MDR Year MDR Reports MDR Events
2020 1714 1714
2021 1403 1415
2022 1055 1055
2023 702 702
2024 534 534
2025 185 185

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

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