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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device ear, nose, and throat surgical tray
Regulation Description Ear, nose, and throat manual surgical instrument.
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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Contamination /Decontamination Problem 2 2
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Break 1 1
Entrapment of Device 1 1
Failure to Read Input Signal 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 2 2
Superficial (First Degree) Burn 2 2
Burn(s) 1 1
Respiratory Distress 1 1
Extubate 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Centurion Medical Products Corporation II Feb-05-2020
3 Centurion Medical Products Corporation II Nov-15-2019
4 Customed, Inc II Apr-14-2016
5 Medline Industries Inc II Jan-07-2021
6 ROi CPS LLC II Nov-18-2021
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