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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 0

MDR Year MDR Reports MDR Events
2019 37 37
2020 24 24
2021 20 20
2022 39 39
2023 19 19
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 47 47
Chemical Problem 21 21
Improper Chemical Reaction 13 13
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
Fluid/Blood Leak 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Device Appears to Trigger Rejection 2 2
Obstruction of Flow 2 2
Failure to Advance 1 1
Fumes or Vapors 1 1
Failure to Infuse 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Loss of or Failure to Bond 1 1
Complete Blockage 1 1
Clumping in Device or Device Ingredient 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 38 38
No Clinical Signs, Symptoms or Conditions 37 37
Cerebrospinal Fluid Leakage 28 28
Unspecified Infection 11 11
Post Operative Wound Infection 7 7
Injury 6 6
Hematoma 4 4
Bacterial Infection 3 3
No Code Available 3 3
Headache 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Paresthesia 2 2
Ambulation Difficulties 2 2
Eye Injury 2 2
Fistula 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Nerve Damage 2 2
Pain 2 2
Visual Impairment 1 1
Neuropathy 1 1
Nausea 1 1
Foreign Body Reaction 1 1
Infarction, Cerebral 1 1
Wound Dehiscence 1 1
Asthma 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Nervous System Injury 1 1
Meningitis 1 1
Quadriplegia 1 1
Skin Tears 1 1
Wheezing 1 1
Intervertebral Disc Compression or Protrusion 1 1
Hydrocephalus 1 1
Neuralgia 1 1

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