• 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 dressing change tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOXQ
Regulation Number 880.5075
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 55 55
2022 7 7
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 52 52
Packaging Problem 51 51
No Apparent Adverse Event 5 5
Nonstandard Device 3 3
Defective Device 2 2
Output Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Product Quality Problem 1 1
Structural Problem 1 1
Leak/Splash 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
Insufficient Information 7 7
Unspecified Infection 6 6
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Itching Sensation 1 1
Burning Sensation 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Centurion Medical Products Corporation II Oct-31-2019
3 Centurion Medical Products Corporation II Oct-09-2019
4 Centurion Medical Products Corporation II Aug-06-2019
5 DeRoyal Industries Inc II Apr-06-2022
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Jan-25-2023
11 Medline Industries Inc II Sep-24-2020
12 ROi CPS LLC I Jan-03-2024
13 ROi CPS LLC II May-07-2021
14 Stradis Healthcare II Sep-08-2022
15 Trinity Sterile, Inc. II Aug-18-2022
16 Trinity Sterile, Inc. II Apr-21-2021
17 Vygon U.S.A. II May-28-2021
-
-