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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neurological 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 CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 8 8
2021 9 9
2022 11 11
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Material Separation 5 5
Material Fragmentation 4 4
Appropriate Term/Code Not Available 4 4
Material Frayed 3 3
Component Incompatible 3 3
Contamination 2 2
Incomplete or Missing Packaging 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Detachment of Device or Device Component 2 2
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1
Unexpected Color 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Flaked 1 1
Inaccurate Flow Rate 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 5 5
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
Local Reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sleep Dysfunction 1 1
Dyspnea 1 1
Headache 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 American Contract Systems, Inc. II May-06-2022
5 Avid Medical, Inc. II Mar-19-2020
6 Cardinal Health 200, LLC II Oct-10-2023
7 Integra LifeSciences Corp. II Mar-22-2022
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-06-2023
11 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
12 Medline Industries Inc II Dec-10-2021
13 ROi CPS LLC II Apr-25-2023
14 ROi CPS LLC II Nov-23-2022
15 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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