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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
Product CodeHEB
Regulation Number 884.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
ALBAAD FEM
  SUBSTANTIALLY EQUIVALENT 3
ALBAAD LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANNES DAYE LTD
  SUBSTANTIALLY EQUIVALENT 1
CALLA LILY PERSONAL CARE, LTD.
  SUBSTANTIALLY EQUIVALENT 3
COTTON HIGH TECH S.L.
  SUBSTANTIALLY EQUIVALENT 3
COTTON HIGH TECH SL
  SUBSTANTIALLY EQUIVALENT 1
COTTON HIGH TECH, S.L.
  SUBSTANTIALLY EQUIVALENT 1
COTTON HIGH TECH, SL
  SUBSTANTIALLY EQUIVALENT 1
COTTONS PTY, LTD
  SUBSTANTIALLY EQUIVALENT 1
CYCLE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONG-A PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FIRST QUALITY HYGIENIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YOAI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 3
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MAXIM HYGIENE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATURALENA BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONTEX BVBA
  SUBSTANTIALLY EQUIVALENT 5
ONTEX INTERNATIONAL NV
  SUBSTANTIALLY EQUIVALENT 1
PLAYTEX MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO YOUJIA HYGIENE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RAEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROSTAM LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU BORAGE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAEBONG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAMPRO INC
  SUBSTANTIALLY EQUIVALENT 1
THE PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 2
THINX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSAMA D.D.
  SUBSTANTIALLY EQUIVALENT 1
TOSAMA D.O.O.
  SUBSTANTIALLY EQUIVALENT 3
TOSAMA, D.O.O.
  SUBSTANTIALLY EQUIVALENT 2
UNIBEAUTY (HUBEI) TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG TIANQING MANUFACTURING TECHNOLOGY GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 167 167
2015 132 132
2016 101 101
2017 194 194
2018 363 363
2019 3034 3034
2020 1714 1714
2021 1404 1416
2022 1055 1055
2023 702 702
2024 378 378

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5098 5098
Insufficient Information 1471 1471
No Apparent Adverse Event 739 739
Adverse Event Without Identified Device or Use Problem 681 693
Break 625 625
Component Missing 357 357
Difficult to Remove 341 341
Product Quality Problem 298 298
Unraveled Material 70 70
Material Fragmentation 65 65
Sharp Edges 52 52
Detachment Of Device Component 41 41
Patient-Device Incompatibility 37 37
Material Integrity Problem 27 27
Misassembled 24 24
Defective Component 23 23
Device Operates Differently Than Expected 22 22
Material Disintegration 20 20
Detachment of Device or Device Component 18 18
Device Contamination with Chemical or Other Material 15 15
Component Falling 14 14
Device Damaged Prior to Use 13 13
Difficult to Insert 12 12
Nonstandard Device 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Material Frayed 9 9
Appropriate Term/Code Not Available 9 9
Material Discolored 7 7
Physical Resistance/Sticking 7 7
Device Contamination with Body Fluid 7 7
Entrapment of Device 6 6
Material Split, Cut or Torn 6 6
Contamination /Decontamination Problem 5 5
Device Or Device Fragments Location Unknown 5 5
Improper or Incorrect Procedure or Method 5 5
Defective Device 4 4
Contamination of Device Ingredient or Reagent 4 4
Lack of Effect 4 4
Loose or Intermittent Connection 4 4
Sticking 3 3
Fungus in Device Environment 3 3
Device Emits Odor 3 3
Separation Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device Contaminated During Manufacture or Shipping 3 3
Use of Device Problem 3 3
Expulsion 3 3
Device Packaging Compromised 3 3
Material Twisted/Bent 3 3
Structural Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2007 2007
No Clinical Signs, Symptoms or Conditions 1589 1589
No Known Impact Or Consequence To Patient 1548 1548
Foreign Body In Patient 1545 1545
Pain 686 686
Irritation 602 602
Discomfort 429 429
Insufficient Information 369 369
Unspecified Infection 328 328
Abnormal Vaginal Discharge 255 255
Bacterial Infection 234 234
Abdominal Pain 183 183
Device Embedded In Tissue or Plaque 180 180
Fungal Infection 165 165
Fever 123 123
Abdominal Cramps 121 121
Toxic Shock Syndrome 116 128
Urinary Tract Infection 115 115
Itching Sensation 110 110
Nausea 90 90
Headache 77 77
Cramp(s) 74 74
Burning Sensation 72 72
Menstrual Irregularities 62 62
Vomiting 58 58
Intermenstrual Bleeding 58 58
Swelling 50 50
Rash 39 39
Chills 35 35
Malaise 34 34
Injury 32 32
Anxiety 32 32
Vaginal Mucosa Damage 31 31
Inflammation 31 31
Diarrhea 30 30
Dizziness 28 28
No Code Available 25 25
Distress 25 25
Cramp(s) /Muscle Spasm(s) 22 22
Skin Irritation 20 20
Hot Flashes/Flushes 19 19
Cyst(s) 19 19
Hemorrhage/Bleeding 18 18
Fatigue 18 18
Skin Inflammation/ Irritation 17 17
Genital Bleeding 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Sweating 13 13
Weakness 11 11
No Information 11 11

Recalls
Manufacturer Recall Class Date Posted
1 First Quality Hygienic Inc II Sep-22-2010
2 Kimberly-Clark Corporation II Jan-17-2019
3 Kimberly-Clark Corporation II Jan-11-2012
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