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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
2016 1 1
2017 8 8
2018 2 2
2019 10 10
2020 8 8
2021 3 3
2022 3 3
2023 7 7
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Component Missing 6 6
Device Contamination with Chemical or Other Material 6 6
Appropriate Term/Code Not Available 4 4
Component Falling 3 3
Fire 2 2
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Defective Device 2 2
Material Split, Cut or Torn 2 2
Suction Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Cut 1 1
Material Separation 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Crack 1 1
Decrease in Suction 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Foreign Body In Patient 3 3
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 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 Customed, Inc II Apr-14-2016
6 Customed, Inc II Sep-03-2015
7 Customed, Inc I Dec-16-2014
8 Customed, Inc I Aug-29-2014
9 DeRoyal Industries Inc II Jun-07-2023
10 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 ROi CPS LLC II Apr-25-2023
14 ROi CPS LLC II Jul-19-2022
15 ROi CPS LLC II Apr-26-2022
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