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 bandage, cast
Product CodeITG
Regulation Number 890.3025
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 5 5
2022 9 9
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Too Soft/Flexible 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Device Slipped 1 1
Break 1 1
Mechanical Problem 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Unsealed Device Packaging 1 1
Failure to Obtain Sample 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Self-Activation or Keying 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Injury 4 4
Partial thickness (Second Degree) Burn 3 3
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Blister 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
No Information 1 1
Skin Disorders 1 1
Rash 1 1
Swelling 1 1
Insufficient Information 1 1
Pain 1 1
Congenital Defect/Deformity 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 1 1
Full thickness (Third Degree) Burn 1 1

-
-