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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator (laryngo-tracheal), topical anesthesia
Product CodeCCT
Regulation Number 868.5170
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Packaging Problem 1 1
Detachment Of Device Component 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 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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