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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ear, nose, and throat surgical tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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 CodeOGR
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2019 3 3
2020 4 4
2021 3 3
2022 6 6
2023 3 3
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 6 6
Material Fragmentation 4 4
Break 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Material Split, Cut or Torn 2 2
Device Markings/Labelling Problem 2 2
Contamination /Decontamination Problem 2 2
Fire 2 2
Contamination of Device Ingredient or Reagent 1 1
Entrapment of Device 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Device Inoperable 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Burn(s) 3 3
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
No Information 2 2
Respiratory Distress 1 1
Extubate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 Cardinal Health 200, LLC II Oct-10-2023
5 Centurion Medical Products Corporation II Feb-05-2020
6 Centurion Medical Products Corporation II Nov-15-2019
7 Customed, Inc II Apr-14-2016
8 Customed, Inc II Sep-03-2015
9 Customed, Inc I Dec-16-2014
10 Customed, Inc I Aug-29-2014
11 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
16 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
17 Medline Industries Inc II Jan-07-2021
18 ROi CPS LLC II Nov-23-2022
19 ROi CPS LLC II Jan-10-2022
20 ROi CPS LLC II Nov-18-2021
21 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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