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 1
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
COTTON HIGH TECH, SL
  SUBSTANTIALLY EQUIVALENT 1
CYCLE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONG-A PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YOAI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ONTEX BVBA
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO YOUJIA HYGIENE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RAEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU BORAGE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAEBONG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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
2019 3034 3034
2020 1714 1714
2021 1404 1416
2022 1055 1055
2023 702 702
2024 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 4450 4450
Insufficient Information 1369 1369
No Apparent Adverse Event 679 679
Adverse Event Without Identified Device or Use Problem 626 638
Break 570 570
Component Missing 349 349
Product Quality Problem 288 288
Difficult to Remove 280 280
Sharp Edges 51 51
Unraveled Material 36 36
Material Fragmentation 31 31
Defective Component 22 22
Misassembled 21 21
Material Integrity Problem 16 16
Patient-Device Incompatibility 14 14
Device Damaged Prior to Use 12 12
Difficult to Insert 12 12
Detachment of Device or Device Component 10 10
Material Disintegration 6 6
Contamination /Decontamination Problem 5 5
Appropriate Term/Code Not Available 5 5
Material Split, Cut or Torn 5 5
Physical Resistance/Sticking 3 3
Separation Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Expulsion 3 3
Use of Device Problem 3 3
Defective Device 3 3
Entrapment of Device 3 3
Loose or Intermittent Connection 3 3
Nonstandard Device 3 3
Mechanical Problem 2 2
Material Frayed 2 2
Device Contaminated During Manufacture or Shipping 2 2
Activation, Positioning or Separation Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Lack of Effect 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Ejection Problem 1 1
Component Misassembled 1 1
Illegible Information 1 1
Device Fell 1 1
Malposition of Device 1 1
Fungus in Device Environment 1 1
Structural Problem 1 1
Collapse 1 1
Contamination 1 1
Degraded 1 1
Unable to Obtain Readings 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1681 1681
No Clinical Signs, Symptoms or Conditions 1509 1509
Foreign Body In Patient 1417 1417
No Known Impact Or Consequence To Patient 1269 1269
Pain 625 625
Irritation 594 594
Insufficient Information 367 367
Discomfort 354 354
Unspecified Infection 306 306
Abnormal Vaginal Discharge 232 232
Bacterial Infection 217 217
Abdominal Pain 163 163
Fungal Infection 155 155
Urinary Tract Infection 112 112
Abdominal Cramps 110 110
Itching Sensation 95 95
Fever 95 95
Device Embedded In Tissue or Plaque 94 94
Toxic Shock Syndrome 77 89
Nausea 73 73
Burning Sensation 68 68
Cramp(s) 63 63
Headache 59 59
Intermenstrual Bleeding 58 58
Menstrual Irregularities 54 54
Vomiting 43 43
Swelling 40 40
Rash 33 33
Anxiety 30 30
Chills 29 29
Injury 29 29
Inflammation 28 28
Vaginal Mucosa Damage 26 26
Diarrhea 25 25
Malaise 23 23
Distress 21 21
Cramp(s) /Muscle Spasm(s) 20 20
Dizziness 19 19
Hot Flashes/Flushes 18 18
Skin Irritation 18 18
Cyst(s) 18 18
Skin Inflammation/ Irritation 17 17
Hemorrhage/Bleeding 16 16
Fatigue 13 13
Genital Bleeding 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Emotional Changes 11 11
Abrasion 10 10
Miscarriage 10 10
Sweating 10 10
Weakness 9 9
Pelvic Inflammatory Disease 8 8
Swelling/ Edema 8 8
Unspecified Tissue Injury 8 8
Loss of consciousness 7 7
Laceration(s) 7 7
Patient Problem/Medical Problem 6 6
Heavier Menses 5 5
Hypersensitivity/Allergic reaction 5 5
Urinary Retention 5 5
Sepsis 5 5
Local Reaction 4 4
Scar Tissue 4 4
Abscess 4 4
Erythema 4 4
Dehydration 4 4
Cervical Changes 4 4
Dysuria 4 4
Urinary Frequency 4 4
No Code Available 4 4
Hematuria 3 3
Ambulation Difficulties 3 3
Adhesion(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Muscle Weakness 3 3
Septic Shock 3 3
Discharge 3 3
Scarring 2 2
Seizures 2 2
High Blood Pressure/ Hypertension 2 2
Foreign Body Reaction 2 2
Anemia 2 2
Dyspnea 2 2
Caustic/Chemical Burns 2 2
Shaking/Tremors 2 2
Confusion/ Disorientation 2 2
Depression 2 2
Numbness 2 2
Collapse 2 2
Missing Value Reason 2 2
Weight Changes 2 2
Intraoperative Pain 2 2
Menorrhagia 2 2
Unspecified Reproductive System or Breast Problem 2 2
Constipation 2 2
Syncope/Fainting 1 1
Movement Disorder 1 1
Cough 1 1
Unspecified Gastrointestinal Problem 1 1
Hormonal Imbalance 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kimberly-Clark Corporation II Jan-17-2019
-
-