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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
2017 1 1
2018 1 1
2019 1 1
2021 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 41 41
Packaging Problem 40 40
Product Quality Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Component Falling 1 1
Leak/Splash 1 1
Torn Material 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 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 Medline Industries Inc II Sep-24-2020
7 ROi CPS LLC II May-07-2021
8 Trinity Sterile, Inc. II Apr-21-2021
9 Vygon U.S.A. II May-28-2021
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