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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plastic surgery and accessories kit
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 CodeFTN
Regulation Number 878.3925
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2
2021 7 7
2022 2 2
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Sparking 2 2
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1
Complete Blockage 1 1
Disconnection 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Material Fragmentation 1 1
Leak/Splash 1 1
Particulates 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Foreign Body In Patient 4 4
Superficial (First Degree) Burn 3 3
Burn(s) 2 2
Insufficient Information 2 2
Rash 2 2
Needle Stick/Puncture 1 1
No Known Impact Or Consequence To 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 Oct-26-2023
4 American Contract Systems, Inc. II Sep-08-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 ROi CPS LLC II Jun-05-2020
10 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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