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 marker, skin
Regulation Description Skin marker.
Product CodeFZZ
Regulation Number 878.4660
Device Class 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 1 1
2023 8 8
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Defective Component 2 2
Defective Device 2 2
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Unspecified Infection 4 4
Abscess 3 3
Insufficient Information 2 2
Necrosis 1 1
Foreign Body In Patient 1 1
Dysphagia/ Odynophagia 1 1
Bacterial Infection 1 1

-
-