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TPLC
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Device
sealant, dural
Definition
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Product Code
NQR
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
3
10
6
4
15
1
MDR Year
MDR Reports
MDR Events
2019
37
37
2020
24
24
2021
20
20
2022
39
39
2023
19
19
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
48
48
Chemical Problem
21
21
Improper Chemical Reaction
14
14
Device Ingredient or Reagent Problem
7
7
Coagulation in Device or Device Ingredient
7
7
Material Integrity Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Leak/Splash
4
4
Defective Device
4
4
Use of Device Problem
4
4
Appropriate Term/Code Not Available
3
3
Fluid/Blood Leak
3
3
Physical Resistance/Sticking
2
2
Obstruction of Flow
2
2
Failure to Power Up
2
2
Product Quality Problem
2
2
Device Appears to Trigger Rejection
2
2
Fumes or Vapors
1
1
Output Problem
1
1
Complete Blockage
1
1
Clumping in Device or Device Ingredient
1
1
Patient-Device Incompatibility
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Device Interaction Problem
1
1
Contamination /Decontamination Problem
1
1
Device Handling Problem
1
1
Failure to Advance
1
1
Failure to Infuse
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
38
38
No Consequences Or Impact To Patient
38
38
Cerebrospinal Fluid Leakage
29
29
Unspecified Infection
11
11
Post Operative Wound Infection
7
7
Injury
6
6
Hematoma
4
4
No Code Available
3
3
Bacterial Infection
3
3
Hypersensitivity/Allergic reaction
2
2
Inflammation
2
2
No Known Impact Or Consequence To Patient
2
2
Paresthesia
2
2
Nerve Damage
2
2
Insufficient Information
2
2
Pain
2
2
Eye Injury
2
2
Headache
2
2
Fistula
2
2
Ambulation Difficulties
2
2
Neuropathy
1
1
Wound Dehiscence
1
1
Infarction, Cerebral
1
1
Nausea
1
1
Wheezing
1
1
Asthma
1
1
Foreign Body Reaction
1
1
Foreign Body In Patient
1
1
Visual Impairment
1
1
Fluid Discharge
1
1
Hydrocephalus
1
1
Skin Tears
1
1
Intervertebral Disc Compression or Protrusion
1
1
Meningitis
1
1
Quadriplegia
1
1
Nervous System Injury
1
1
Neuralgia
1
1
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