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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device splint, intranasal septal
Regulation Description Intranasal splint.
Product CodeLYA
Regulation Number 874.4780
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMED ENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED
  SUBSTANTIALLY EQUIVALENT 1
SPIWAY, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 19 19
2022 8 8
2023 17 17
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Material Integrity Problem 11 11
Packaging Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5
Migration or Expulsion of Device 3 3
Use of Device Problem 3 3
Material Too Rigid or Stiff 2 2
Contamination of Device Ingredient or Reagent 2 2
Activation Failure 2 2
Device Dislodged or Dislocated 2 2
Unexpected Therapeutic Results 2 2
Patient-Device Incompatibility 1 1
Microbial Contamination of Device 1 1
Material Discolored 1 1
Delivered as Unsterile Product 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Contamination with Chemical or Other Material 1 1
Over-Sensing 1 1
Melted 1 1
Nonstandard Device 1 1
High Capture Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Pain 12 12
Headache 12 12
Swelling/ Edema 7 7
Hemorrhage/Bleeding 6 6
Post Traumatic Wound Infection 4 4
Unspecified Tissue Injury 3 3
Respiratory Insufficiency 3 3
Unspecified Infection 2 2
Inflammation 2 2
Blood Loss 2 2
Epistaxis 2 2
Bacterial Infection 2 2
Skin Infection 1 1
Necrosis 1 1
Adhesion(s) 1 1
Hematoma 1 1
Perforation 1 1
Scarring 1 1
Cellulitis 1 1
Post Operative Wound Infection 1 1
Seroma 1 1
Foreign Body In Patient 1 1
Fall 1 1
Scar Tissue 1 1
Prolapse 1 1
Therapeutic Response, Decreased 1 1
Deformity/ Disfigurement 1 1
Loss of consciousness 1 1
Eye Pain 1 1
Granuloma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GELITA MEDICAL GMBH II Sep-19-2022
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