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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNQR
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
4 2 6 3 10 6 4 15 1

MDR Year MDR Reports MDR Events
2016 23 23
2017 29 29
2018 45 45
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 68 68
Appropriate Term/Code Not Available 37 37
Chemical Problem 23 23
Device Operates Differently Than Expected 18 18
Improper Chemical Reaction 15 15
Fluid/Blood Leak 10 10
Insufficient Information 10 10
Material Integrity Problem 9 9
Leak/Splash 8 8
Failure To Adhere Or Bond 8 8
Device Ingredient or Reagent Problem 7 7
Coagulation in Device or Device Ingredient 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Product Quality Problem 5 5
Defective Device 4 4
Use of Device Problem 4 4
Patient-Device Incompatibility 3 3
Off-Label Use 3 3
Device Operational Issue 3 3
Device Contamination with Chemical or Other Material 3 3
Device Appears to Trigger Rejection 2 2
Physical Resistance/Sticking 2 2
Patient Device Interaction Problem 2 2
Contamination 2 2
Failure to Power Up 2 2
Component Missing 2 2
Obstruction of Flow 2 2
Failure to Infuse 1 1
Failure to Advance 1 1
Material Separation 1 1
Sticking 1 1
Volume Accuracy Problem 1 1
Output Problem 1 1
Device Handling Problem 1 1
Complete Blockage 1 1
Packaging Problem 1 1
Clumping in Device or Device Ingredient 1 1
Contamination /Decontamination Problem 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Air Leak 1 1
Shipping Damage or Problem 1 1
Shelf Life Exceeded 1 1
Device Difficult to Setup or Prepare 1 1
Device Packaging Compromised 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged by Another Device 1 1
Out-Of-Box Failure 1 1
Fumes or Vapors 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 68 68
No Consequences Or Impact To Patient 57 57
No Clinical Signs, Symptoms or Conditions 38 38
Unspecified Infection 19 19
No Known Impact Or Consequence To Patient 14 14
Meningitis 13 13
Inflammation 9 9
Injury 9 9
Post Operative Wound Infection 8 8
No Code Available 7 7
Fever 7 7
Bacterial Infection 6 6
Swelling 6 6
No Patient Involvement 6 6
Purulent Discharge 5 5
Pain 5 5
Fistula 4 4
Headache 4 4
Hematoma 4 4
No Information 3 3
Hydrocephalus 3 3
Ambulation Difficulties 2 2
Organ Dehiscence 2 2
Eye Injury 2 2
Visual Impairment 2 2
Insufficient Information 2 2
Nerve Damage 2 2
Paresthesia 2 2
Hypersensitivity/Allergic reaction 2 2
Infarction, Cerebral 2 2
Wound Dehiscence 2 2
Paralysis 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Foreign Body Reaction 1 1
Neurological Deficit/Dysfunction 1 1
Confusion/ Disorientation 1 1
Staphylococcus Aureus 1 1
Paresis 1 1
Spinal Column Injury 1 1
Reaction 1 1
Asthma 1 1
Dry Eye(s) 1 1
Fluid Discharge 1 1
Anaphylactic Shock 1 1
Wheezing 1 1
Nausea 1 1
Aneurysm 1 1
Intervertebral Disc Compression or Protrusion 1 1
Skin Tears 1 1

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