Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
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 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5067 5067
Insufficient Information 1369 1369
No Apparent Adverse Event 666 666
Adverse Event Without Identified Device or Use Problem 639 651
Break 605 605
Component Missing 354 354
Difficult to Remove 338 338
Product Quality Problem 292 292
Unraveled Material 70 70
Material Fragmentation 65 65
Sharp Edges 51 51
Detachment Of Device Component 41 41
Patient-Device Incompatibility 36 36
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
Physical Resistance/Sticking 7 7
Material Discolored 7 7
Device Contamination with Body Fluid 7 7
Entrapment of Device 6 6
Material Split, Cut or Torn 6 6
Improper or Incorrect Procedure or Method 5 5
Contamination /Decontamination Problem 5 5
Device Or Device Fragments Location Unknown 5 5
Defective Device 4 4
Contamination of Device Ingredient or Reagent 4 4
Loose or Intermittent Connection 4 4
Use of Device Problem 3 3
Sticking 3 3
Device Emits Odor 3 3
Fungus in Device Environment 3 3
Structural Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Twisted/Bent 3 3
Expulsion 3 3
Device Packaging Compromised 3 3
Separation Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Torn Material 2 2
Positioning Problem 2 2
Device Fell 2 2
Lack of Effect 2 2
Extrusion 2 2
Material Deformation 2 2
Split 2 2
Microbial Contamination of Device 2 2
Out-Of-Box Failure 2 2
Activation, Positioning or Separation Problem 2 2
Unsealed Device Packaging 2 2
Stretched 2 2
Device Slipped 2 2
Mechanical Problem 2 2
Leak/Splash 2 2
Contamination 2 2
Degraded 1 1
Disassembly 1 1
Material Erosion 1 1
Flaked 1 1
Looping 1 1
Collapse 1 1
Particulates 1 1
Off-Label Use 1 1
Unable to Obtain Readings 1 1
Malposition of Device 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Mechanical Jam 1 1
Material Protrusion/Extrusion 1 1
Device Contamination With Biological Material 1 1
Device Dislodged or Dislocated 1 1
Environmental Particulates 1 1
Illegible Information 1 1
Ejection Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2007 2007
No Known Impact Or Consequence To Patient 1548 1548
No Clinical Signs, Symptoms or Conditions 1484 1484
Foreign Body In Patient 1432 1432
Pain 660 660
Irritation 602 602
Discomfort 406 406
Insufficient Information 364 364
Unspecified Infection 326 326
Abnormal Vaginal Discharge 249 249
Bacterial Infection 233 233
Abdominal Pain 181 181
Device Embedded In Tissue or Plaque 180 180
Fungal Infection 165 165
Abdominal Cramps 119 119
Fever 119 119
Toxic Shock Syndrome 115 127
Urinary Tract Infection 115 115
Itching Sensation 107 107
Nausea 87 87
Headache 74 74
Cramp(s) 74 74
Burning Sensation 71 71
Menstrual Irregularities 59 59
Intermenstrual Bleeding 58 58
Vomiting 57 57
Swelling 50 50
Rash 37 37
Chills 34 34
Malaise 33 33
Injury 32 32
Anxiety 31 31
Inflammation 29 29
Diarrhea 29 29
Dizziness 28 28
Vaginal Mucosa Damage 26 26
No Code Available 25 25
Distress 23 23
Skin Irritation 20 20
Cramp(s) /Muscle Spasm(s) 20 20
Cyst(s) 19 19
Hot Flashes/Flushes 19 19
Hemorrhage/Bleeding 18 18
Fatigue 17 17
Skin Inflammation/ Irritation 17 17
Sweating 13 13
Weakness 11 11
No Information 11 11
Genital Bleeding 11 11
Abrasion 11 11
Emotional Changes 10 10
Pelvic Inflammatory Disease 10 10
Miscarriage 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Erythema 9 9
Low Blood Pressure/ Hypotension 9 9
Laceration(s) 9 9
Patient Problem/Medical Problem 9 9
Heavier Menses 9 9
No Patient Involvement 9 9
Complaint, Ill-Defined 9 9
Loss of consciousness 9 9
Unspecified Tissue Injury 8 8
Swelling/ Edema 8 8
Dysuria 7 7
Shaking/Tremors 7 7
Hypersensitivity/Allergic reaction 7 7
Scar Tissue 7 7
Sepsis 6 6
Urinary Retention 5 5
Fainting 5 5
Abscess 5 5
Discharge 5 5
Urinary Frequency 4 4
Coma 4 4
Confusion/ Disorientation 4 4
Ambulation Difficulties 4 4
Cervical Changes 4 4
Dehydration 4 4
Local Reaction 4 4
Muscle Weakness 4 4
Scarring 3 3
Seizures 3 3
Septic Shock 3 3
Syncope 3 3
Adhesion(s) 3 3
Fungus 3 3
Hematuria 3 3
Caustic/Chemical Burns 2 2
Intraoperative Pain 2 2
Abdominal Distention 2 2
Weight Changes 2 2
Missing Value Reason 2 2
Multiple Organ Failure 2 2
Menorrhagia 2 2
Unspecified Reproductive System or Breast Problem 2 2
Constipation 2 2
Reaction 2 2
Numbness 2 2
Collapse 2 2

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
-
-