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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 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 6 6
Break 6 6
Material Fragmentation 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
Fire 2 2
Contamination /Decontamination Problem 2 2
Failure to Read Input Signal 1 1
Crack 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Operates Differently Than Expected 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Material Deformation 1 1
Fluid/Blood Leak 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 6 6
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Burn(s) 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 II Sep-11-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
17 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
22 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
23 Medline Industries Inc II Jan-07-2021
24 ROi CPS LLC II Nov-23-2022
25 ROi CPS LLC II Jan-10-2022
26 ROi CPS LLC II Nov-18-2021
27 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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