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
cup, menstrual
Product Code
HHE
Regulation Number
884.5400
Device Class
2
Premarket Reviews
Manufacturer
Decision
APEX MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
FEMCAP INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
LIBRETTE, INC
SUBSTANTIALLY EQUIVALENT
1
LUNE GROUP LTD.
SUBSTANTIALLY EQUIVALENT
1
MELUNA
SUBSTANTIALLY EQUIVALENT
1
MENSTRUAL MATES
SUBSTANTIALLY EQUIVALENT
1
SCKOON INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
2
2
2016
1
1
2017
4
4
2018
1
1
2019
22
22
2020
220
220
2021
40
40
2022
26
26
2023
133
133
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Remove
261
261
Patient Device Interaction Problem
188
188
Adverse Event Without Identified Device or Use Problem
34
34
Patient-Device Incompatibility
12
12
Insufficient Information
10
10
Suction Problem
9
9
Break
8
8
Device-Device Incompatibility
6
6
Compatibility Problem
5
5
Appropriate Term/Code Not Available
5
5
Device Dislodged or Dislocated
5
5
Expulsion
4
4
Improper or Incorrect Procedure or Method
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Entrapment of Device
2
2
Migration or Expulsion of Device
2
2
Product Quality Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Microbial Contamination of Device
1
1
Use of Device Problem
1
1
Device Handling Problem
1
1
Leak/Splash
1
1
Fitting Problem
1
1
Material Split, Cut or Torn
1
1
Device Slipped
1
1
Activation, Positioning or Separation Problem
1
1
Physical Resistance/Sticking
1
1
Malposition of Device
1
1
Output Problem
1
1
Difficult to Fold, Unfold or Collapse
1
1
Unintended Movement
1
1
Positioning Problem
1
1
Detachment of Device or Device Component
1
1
Sticking
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
177
177
Pain
50
50
Therapeutic Effects, Unexpected
44
44
No Known Impact Or Consequence To Patient
43
43
No Clinical Signs, Symptoms or Conditions
41
41
Insufficient Information
28
28
Urinary Tract Infection
16
16
Unspecified Infection
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
No Code Available
9
9
Hypersensitivity/Allergic reaction
8
8
Bacterial Infection
7
7
Prolapse
7
7
Discomfort
7
7
Abdominal Pain
7
7
Fungal Infection
7
7
Local Reaction
6
6
Fever
6
6
Nausea
5
5
Toxic Shock Syndrome
5
5
Intermenstrual Bleeding
5
5
Unspecified Reproductive System or Breast Problem
4
4
Device Embedded In Tissue or Plaque
4
4
Patient Problem/Medical Problem
4
4
Abnormal Vaginal Discharge
4
4
Laceration(s)
4
4
Menstrual Irregularities
4
4
Tachycardia
3
3
Rash
3
3
Hemorrhage/Bleeding
2
2
Tissue Damage
2
2
Swelling/ Edema
2
2
Swelling
2
2
Diarrhea
2
2
Burning Sensation
2
2
Irritation
2
2
Sepsis
2
2
Skin Irritation
2
2
Not Applicable
2
2
Anemia
2
2
Genital Bleeding
2
2
Cyst(s)
2
2
Distress
1
1
Thyroid Problems
1
1
Neuralgia
1
1
Abortion
1
1
Low Blood Pressure/ Hypotension
1
1
Hyperemia
1
1
Headache
1
1
Cervical Changes
1
1
-
-