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
Regulation Description Unscented menstrual tampon.
Definition An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
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 3
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 3
ZHEJIANG TIANQING MANUFACTURING TECHNOLOGY GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1714 1716
2021 1403 1416
2022 1055 1055
2023 702 702
2024 534 534
2025 385 385

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1886 1886
Insufficient Information 1685 1685
No Apparent Adverse Event 907 907
Adverse Event Without Identified Device or Use Problem 727 739
Break 410 410
Component Missing 313 313
Product Quality Problem 282 282
Difficult to Remove 249 249
Sharp Edges 37 37
Material Fragmentation 28 28
Defective Component 19 19
Unraveled Material 18 20
Difficult to Insert 13 13
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 5
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
Microbial Contamination of Device 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
Device Emits Odor 1 1
Material Protrusion/Extrusion 1 1
Material Frayed 1 2
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 1804 1804
Foreign Body In Patient 1755 1755
No Consequences Or Impact To Patient 938 938
Pain 399 400
Insufficient Information 390 390
No Known Impact Or Consequence To Patient 351 353
Discomfort 306 307
Abnormal Vaginal Discharge 87 87
Device Embedded In Tissue or Plaque 80 80
Abdominal Pain 66 66
Abdominal Cramps 62 62
Unspecified Infection 53 53
Bacterial Infection 41 41
Itching Sensation 39 39
Burning Sensation 39 39
Fever 38 38
Toxic Shock Syndrome 37 49
Nausea 36 36
Vaginal Mucosa Damage 32 32
Cramp(s) /Muscle Spasm(s) 30 30
Headache 30 30
Menstrual Irregularities 28 28
Anxiety 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Skin Inflammation/ Irritation 21 21
Fungal Infection 20 20
Malaise 19 19
Diarrhea 17 17
Cramp(s) 16 16
Genital Bleeding 16 16
Intermenstrual Bleeding 16 16
Urinary Tract Infection 14 14
Vomiting 14 14
Rash 14 14
Distress 13 13
Swelling/ Edema 13 13
Hemorrhage/Bleeding 12 13
Inflammation 12 12
Irritation 11 11
Chills 11 11
Unspecified Tissue Injury 11 11
Emotional Changes 11 11
Hypersensitivity/Allergic reaction 10 10
Dizziness 7 7
Fatigue 7 7
Abdominal Distention 6 6
Abrasion 6 6
Dysuria 6 6
Swelling 6 6
Erythema 6 6

Recalls
Manufacturer Recall Class Date Posted
1 DAYE (ANNE'S DAY LTD) II Oct-28-2025
-
-