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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
ALBAAD FEM
  SUBSTANTIALLY EQUIVALENT 3
CALLA LILY PERSONAL CARE, LTD.
  SUBSTANTIALLY EQUIVALENT 3
COTTON HIGH TECH S.L.
  SUBSTANTIALLY EQUIVALENT 2
COTTON HIGH TECH, SL
  SUBSTANTIALLY EQUIVALENT 1
CYCLE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONG-A PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FIRST QUALITY HYGIENIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YOAI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ONTEX BVBA
  SUBSTANTIALLY EQUIVALENT 2
PLAYTEX MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO YOUJIA HYGIENE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RAEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAEBONG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THINX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSAMA, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 101 101
2017 194 194
2018 363 363
2019 3034 3034
2020 1714 1714
2021 1230 1242

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 4275 4275
Insufficient Information 671 671
Break 472 472
Adverse Event Without Identified Device or Use Problem 322 334
Component Missing 315 315
No Apparent Adverse Event 277 277
Difficult to Remove 228 228
Product Quality Problem 212 212
Unraveled Material 56 56
Sharp Edges 47 47
Patient-Device Incompatibility 31 31
Material Fragmentation 31 31
Misassembled 24 24
Defective Component 19 19
Material Integrity Problem 19 19
Detachment of Device or Device Component 16 16
Material Disintegration 14 14
Device Damaged Prior to Use 12 12
Detachment Of Device Component 11 11
Nonstandard Device 11 11
Device Operates Differently Than Expected 8 8
Appropriate Term/Code Not Available 7 7
Physical Resistance/Sticking 5 5
Contamination /Decontamination Problem 5 5
Difficult to Insert 5 5
Material Frayed 4 4
Entrapment of Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Expulsion 3 3
Device Contamination with Chemical or Other Material 3 3
Separation Problem 3 3
Material Split, Cut or Torn 3 3
Loose or Intermittent Connection 3 3
Mechanical Problem 2 2
Stretched 2 2
Fungus in Device Environment 2 2
Device Contamination with Body Fluid 2 2
Leak/Splash 2 2
Device Fell 2 2
Torn Material 2 2
Activation, Positioning or SeparationProblem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Packaging Compromised 1 1
Contamination of Device Ingredient or Reagent 1 1
Out-Of-Box Failure 1 1
Component Misassembled 1 1
Ejection Problem 1 1
Illegible Information 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Material Erosion 1 1
Flaked 1 1
Component Falling 1 1
Material Discolored 1 1
Collapse 1 1
Device Issue 1 1
Structural Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Slipped 1 1
Sticking 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1972 1972
No Known Impact Or Consequence To Patient 1444 1444
Foreign Body In Patient 633 633
Irritation 601 601
No Clinical Signs, Symptoms or Conditions 583 583
Pain 507 507
Unspecified Infection 302 302
Discomfort 279 279
Abnormal Vaginal Discharge 212 212
Bacterial Infection 211 211
Insufficient Information 168 168
Abdominal Pain 161 161
Fungal Infection 157 157
Device Embedded In Tissue or Plaque 111 111
Urinary Tract Infection 110 110
Fever 104 104
Itching Sensation 96 96
Abdominal Cramps 95 95
Toxic Shock Syndrome 89 101
Nausea 71 71
Cramp(s) 68 68
Burning Sensation 62 62
Headache 55 55
Intermenstrual Bleeding 55 55
Menstrual Irregularities 51 51
Vomiting 48 48
Swelling 47 47
Chills 31 31
Injury 31 31
Rash 26 26
Inflammation 25 25
Diarrhea 23 23
Dizziness 23 23
Malaise 22 22
Skin Irritation 20 20
Hot Flashes/Flushes 19 19
Distress 18 18
Cyst(s) 17 17
Anxiety 16 16
Sweating 13 13
Hemorrhage/Bleeding 13 13
Fatigue 13 13
No Code Available 11 11
Miscarriage 10 10
Weakness 10 10
Pelvic Inflammatory Disease 9 9
Patient Problem/Medical Problem 9 9
Heavier Menses 8 8
Abrasion 8 8
Scar Tissue 7 7
Sepsis 6 6
Vaginal Mucosa Damage 6 6
No Information 6 6
Dysuria 5 5
Loss of consciousness 5 5
Shaking/Tremors 5 5
Discharge 5 5
Laceration(s) 5 5
Abscess 5 5
Low Blood Pressure/ Hypotension 5 5
Fainting 4 4
Dehydration 4 4
Swelling/ Edema 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Complaint, Ill-Defined 3 3
No Patient Involvement 3 3
Ambulation Difficulties 3 3
Adhesion(s) 3 3
Erythema 3 3
Fungus 3 3
Seizures 3 3
Urinary Retention 3 3
Scarring 2 2
Septic Shock 2 2
Peeling 2 2
Anemia 2 2
Syncope 2 2
Weight Changes 2 2
Collapse 2 2
Urinary Frequency 2 2
Unspecified Tissue Injury 2 2
Missing Value Reason 2 2
Pregnancy 1 1
Multiple Organ Failure 1 1
Cancer 1 1
Constipation 1 1
Pregnancy with a Contraceptive Device 1 1
Urinary Incontinence 1 1
Blister 1 1
Fluid Discharge 1 1
Alteration In Body Temperature 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Viral Infection 1 1
Coma 1 1
Depression 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Caustic/Chemical Burns 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1

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