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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
applicator (laryngo-tracheal), topical anesthesia
Product Code
CCT
Regulation Number
868.5170
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDICA HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
N.M. BEALE CO. INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
4
4
2017
2
2
2021
3
3
2022
3
3
2023
2
2
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5
5
Crack
2
2
Disconnection
1
1
Detachment of Device or Device Component
1
1
Material Separation
1
1
Device Dislodged or Dislocated
1
1
Connection Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Detachment Of Device Component
1
1
Migration or Expulsion of Device
1
1
Material Fragmentation
1
1
Packaging Problem
1
1
Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3
3
Foreign Body In Patient
3
3
Insufficient Information
3
3
No Patient Involvement
2
2
No Information
1
1
No Known Impact Or Consequence To Patient
1
1
Discomfort
1
1
No Consequences Or Impact To Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sharn, Inc.
II
Nov-16-2009
2
Teleflex Medical
II
Aug-25-2017
3
Teleflex Medical
II
Nov-09-2016
4
Teleflex Medical Europe Ltd
II
May-23-2018
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