Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
tampon, menstrual, unscented
Product Code
HEB
Regulation Number
884.5470
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
-
-