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 elastomer, silicone, for scar management
Regulation Description Silicone sheeting.
Product CodeMDA
Regulation Number 878.4025
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2023 8 8
2025 3 3
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 3 3
Biocompatibility 2 2
Gel Leak 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
Hypersensitivity/Allergic reaction 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Erythema 3 3
Blister 3 3
Rash 3 3
Inflammation 2 2
Local Reaction 2 2
Sepsis 2 2
Swelling/ Edema 2 2
Deformity/ Disfigurement 2 2
Itching Sensation 1 1
Visual Impairment 1 1
Skin Tears 1 1
Scar Tissue 1 1
Abscess 1 1
Burn(s) 1 1
Blurred Vision 1 1
Caustic/Chemical Burns 1 1
Fluid Discharge 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Urticaria 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Contact Dermatitis 1 1
Ulcer 1 1

-
-