• 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
2017 1 1
2018 1 1
2019 1 1
2021 55 55
2022 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 3 3
Product Quality Problem 2 2
Patient-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Defective Device 1 1
Break 1 1
Component Falling 1 1
Leak/Splash 1 1
Physical Resistance/Sticking 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Unspecified Infection 6 6
Insufficient Information 3 3
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
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 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 Centurion Medical Products Corporation II Mar-27-2017
6 DeRoyal Industries Inc II Apr-06-2022
7 Medline Industries Inc II Sep-24-2020
8 ROi CPS LLC II May-07-2021
9 Trinity Sterile, Inc. II Apr-21-2021
10 Vygon U.S.A. II May-28-2021
-
-