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
2019 18 18
2020 14 14
2021 12 12
2022 1 1
2023 8 8
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 15 15
Adverse Event Without Identified Device or Use Problem 10 10
Defective Component 10 10
Defective Device 9 9
Off-Label Use 2 2
Detachment of Device or Device Component 2 2
Use of Device Problem 1 1
Unintended Movement 1 1
Material Separation 1 1
Material Integrity Problem 1 1
Leak/Splash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 12 12
Unspecified Infection 7 7
Abscess 6 6
No Consequences Or Impact To Patient 5 5
No Patient Involvement 5 5
Necrosis 3 3
Inflammation 3 3
Insufficient Information 2 2
Bacterial Infection 1 1
Dysphagia/ Odynophagia 1 1
Edema 1 1
Foreign Body In Patient 1 1

-
-