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TPLC
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show TPLC since
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2024
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Device
splint, intranasal septal
Product Code
LYA
Regulation Number
874.4780
Device Class
1
Premarket Reviews
Manufacturer
Decision
BIOMED ENT, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC XOMED
SUBSTANTIALLY EQUIVALENT
1
SPIWAY, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
6
6
2021
19
19
2022
8
8
2023
17
17
2024
4
4
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
Use of Device Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Patient-Device Incompatibility
3
3
Migration or Expulsion of Device
3
3
Material Too Rigid or Stiff
2
2
Contamination of Device Ingredient or Reagent
2
2
Device Dislodged or Dislocated
2
2
Unexpected Therapeutic Results
2
2
Activation Failure
2
2
Migration
1
1
Microbial Contamination of Device
1
1
Device Contamination with Chemical or Other Material
1
1
Inadequacy of Device Shape and/or Size
1
1
Nonstandard Device
1
1
Material Discolored
1
1
Material Disintegration
1
1
Labelling, Instructions for Use or Training Problem
1
1
Melted
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
Headache
12
12
Pain
12
12
Hemorrhage/Bleeding
6
6
Swelling/ Edema
6
6
Post Traumatic Wound Infection
4
4
Respiratory Insufficiency
3
3
Unspecified Tissue Injury
3
3
Scarring
3
3
Bacterial Infection
2
2
Epistaxis
2
2
Blood Loss
2
2
Inflammation
2
2
Necrosis
1
1
Prolapse
1
1
Foreign Body In Patient
1
1
Eye Pain
1
1
Skin Infection
1
1
Cellulitis
1
1
Granuloma
1
1
Adhesion(s)
1
1
Airway Obstruction
1
1
Unspecified Infection
1
1
Hematoma
1
1
Seroma
1
1
No Consequences Or Impact To Patient
1
1
Therapeutic Response, Decreased
1
1
Injury
1
1
Deformity/ Disfigurement
1
1
Post Operative Wound Infection
1
1
Perforation
1
1
Respiratory Distress
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GELITA MEDICAL GMBH
II
Sep-19-2022
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