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TPLC
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Device
airway, oropharyngeal, anesthesiology
Regulation Description
Oropharyngeal airway.
Product Code
CAE
Regulation Number
868.5110
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
30
30
2021
62
62
2022
51
51
2023
52
52
2024
59
59
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
50
50
Inflation Problem
19
19
Leak/Splash
17
17
Material Separation
17
17
Deflation Problem
16
16
Break
13
13
Adverse Event Without Identified Device or Use Problem
12
12
Detachment of Device or Device Component
8
8
Disconnection
6
6
Material Split, Cut or Torn
6
6
Contamination /Decontamination Problem
5
5
Material Puncture/Hole
5
5
Use of Device Problem
5
5
Appropriate Term/Code Not Available
5
5
Patient Device Interaction Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Obstruction of Flow
4
4
Structural Problem
4
4
Material Integrity Problem
3
3
Material Rupture
3
3
Device Handling Problem
3
3
Deformation Due to Compressive Stress
3
3
Physical Resistance/Sticking
3
3
Insufficient Information
3
3
Material Deformation
3
3
Separation Problem
3
3
Pressure Problem
3
3
Nonstandard Device
3
3
Device Dislodged or Dislocated
3
3
Fracture
2
2
Delivered as Unsterile Product
2
2
Fitting Problem
2
2
Defective Device
2
2
Material Fragmentation
2
2
Difficult to Insert
2
2
Infusion or Flow Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Complete Blockage
2
2
Device Markings/Labelling Problem
2
2
Defective Component
1
1
Shipping Damage or Problem
1
1
Inaccurate Information
1
1
Device Damaged Prior to Use
1
1
Dent in Material
1
1
Mechanical Problem
1
1
Migration or Expulsion of Device
1
1
Malposition of Device
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Melted
1
1
Material Too Rigid or Stiff
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
166
166
Insufficient Information
25
25
No Consequences Or Impact To Patient
9
9
No Patient Involvement
6
6
No Known Impact Or Consequence To Patient
6
6
Pain
5
5
Foreign Body In Patient
5
5
Low Oxygen Saturation
4
4
Airway Obstruction
3
3
Cardiac Arrest
3
3
Hypoxia
3
3
Unintended Extubation
3
3
Numbness
3
3
Respiratory Insufficiency
2
2
Cyanosis
2
2
Ecchymosis
2
2
Hypoventilation
2
2
Laceration(s)
1
1
Pulmonary Edema
1
1
Bronchospasm
1
1
Device Embedded In Tissue or Plaque
1
1
Respiratory Arrest
1
1
Unspecified Gastrointestinal Problem
1
1
Abrasion
1
1
Bruise/Contusion
1
1
Death
1
1
Erythema
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Unspecified Tissue Injury
1
1
Implant Pain
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Ulcer
1
1
Pressure Sores
1
1
Laceration(s) of Esophagus
1
1
Obstruction/Occlusion
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bound Tree Medical
II
Jul-10-2020
2
Intersurgical Inc
II
Oct-17-2022
3
King Systems Corp. dba Ambu, Inc.
II
Oct-30-2024
4
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
5
MEDLINE INDUSTRIES, LP - Northfield
I
Feb-25-2024
6
MEDLINE INDUSTRIES, LP - Northfield
II
Jul-21-2023
7
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-14-2022
8
Sarnova HC, Llc
II
Jan-12-2024
9
SunMed Holdings, LLC
II
Jan-26-2023
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