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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)
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
Manufacturing, Packaging or Shipping Problem 5 5
Material Integrity 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
Failure to Power Up 2 2
Obstruction of Flow 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
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Device Handling Problem 1 1
Failure to Infuse 1 1
Failure to Advance 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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