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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
2024 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
Adverse Event Without Identified Device or Use Problem 3 3
Nonstandard Device 3 3
Defective Component 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Physical Resistance/Sticking 1 1
Structural Problem 1 1
Leak/Splash 1 1
Product Quality Problem 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 5 5
Erythema 3 3
Itching Sensation 3 3
Rash 3 3
Burning Sensation 1 1
Anaphylactoid 1 1
No Patient Involvement 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 II Mar-29-2024
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jan-25-2023
12 Medline Industries Inc II Sep-24-2020
13 ROi CPS LLC I Jan-03-2024
14 ROi CPS LLC II May-07-2021
15 Stradis Healthcare II Sep-08-2022
16 Trinity Sterile, Inc. II Aug-18-2022
17 Trinity Sterile, Inc. II Apr-21-2021
18 Vygon U.S.A. II May-28-2021
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