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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
Regulation Description Elastic bandage.
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
2021 55 55
2022 7 7
2023 6 6
2024 12 12
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Packaging Problem 52 52
Unsealed Device Packaging 51 51
Defective Device 5 5
No Apparent Adverse Event 5 5
Component Missing 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Nonstandard Device 3 3
Output Problem 2 2
Patient-Device Incompatibility 2 2
Defective Component 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Leak/Splash 1 1
Device Ingredient or Reagent Problem 1 1
Physical Resistance/Sticking 1 1
Patient Device Interaction Problem 1 1
Structural Problem 1 1
Product Quality Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Insufficient Information 9 9
Unspecified Infection 6 6
Hypersensitivity/Allergic reaction 6 6
Itching Sensation 4 4
Rash 4 4
Skin Inflammation/ Irritation 3 3
Erythema 3 3
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Anaphylactoid 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 DeRoyal Industries Inc II Apr-06-2022
3 MEDLINE INDUSTRIES, LP - Northfield II Jan-28-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Jan-25-2023
14 Medline Industries Inc II Sep-24-2020
15 ROi CPS LLC I Jan-03-2024
16 ROi CPS LLC II May-07-2021
17 Stradis Healthcare II Sep-08-2022
18 Trinity Sterile, Inc. II Jan-22-2025
19 Trinity Sterile, Inc. II Aug-18-2022
20 Trinity Sterile, Inc. II Apr-21-2021
21 Vygon U.S.A. II May-28-2021
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