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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cesarean section 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 CodeOHM
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2019 10 10
2020 8 8
2021 3 3
2022 3 3
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 5 5
Break 4 4
Device Contamination with Chemical or Other Material 4 4
Delivered as Unsterile Product 2 2
Defective Device 2 2
Material Split, Cut or Torn 2 2
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Appropriate Term/Code Not Available 1 1
Decrease in Suction 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Cut 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 1 1
No Patient Involvement 1 1
Foreign Body In Patient 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 DeRoyal Industries Inc II Jun-07-2023
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 ROi CPS LLC II Apr-25-2023
10 ROi CPS LLC II Jul-19-2022
11 ROi CPS LLC II Apr-26-2022
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