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, scented, scented-deodorized
Regulation Description Scented or scented deodorized menstrual tampon.
Definition A scented or scented-deodorized 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 CodeHIL
Regulation Number 884.5460
Device Class 2

MDR Year MDR Reports MDR Events
2020 12 12
2021 7 7
2022 2 3
2023 1 1
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 9 9
No Apparent Adverse Event 6 6
Material Separation 3 3
Entrapment of Device 1 1
Malposition of Device 1 2
Defective Component 1 1
Degraded 1 1
Device Emits Odor 1 2
Product Quality Problem 1 1
Detachment of Device or Device Component 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 13 14
No Clinical Signs, Symptoms or Conditions 5 5
Device Embedded In Tissue or Plaque 5 5
Bacterial Infection 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
Menstrual Irregularities 1 1
Abnormal Vaginal Discharge 1 1
Skin Inflammation/ Irritation 1 1
Local Reaction 1 1
Burning Sensation 1 1
Pain 1 1

-
-