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 pad, menstrual, scented
Product CodeHHL
Regulation Number 884.5425
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2016 4 4
2017 1 1
2019 3 3
2022 1 1
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 9 9
Insufficient Information 4 4
Device Emits Odor 1 1
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7 7
Rash 5 5
Burning Sensation 5 5
Hypersensitivity/Allergic reaction 5 5
Reaction 4 4
Bacterial Infection 3 3
Discomfort 3 3
Itching Sensation 2 2
Fungal Infection 2 2
Sleep Dysfunction 1 1
Paresthesia 1 1
Angioedema 1 1
Blister 1 1
Localized Skin Lesion 1 1
Skin Infection 1 1
Subcutaneous Nodule 1 1
Menstrual Irregularities 1 1
Unspecified Infection 1 1
Irritation 1 1
Burn(s) 1 1
Dysphagia/ Odynophagia 1 1
Erythema 1 1
Headache 1 1
Malaise 1 1
Sore Throat 1 1
Respiratory Distress 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Swelling 1 1
Urinary Tract Infection 1 1

-
-