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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
3 2 6 3 10 2

MDR Year MDR Reports MDR Events
2016 23 23
2017 29 29
2018 45 45
2019 37 37
2020 24 24
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Appropriate Term/Code Not Available 37 37
Device Operates Differently Than Expected 18 18
Chemical Problem 13 13
Fluid Leak 10 10
Insufficient Information 10 10
Material Integrity Problem 9 9
Improper Chemical Reaction 8 8
Failure To Adhere Or Bond 8 8
Device Ingredient or Reagent Problem 7 7
Leak/Splash 5 5
Product Quality Problem 5 5
Defective Device 4 4
Use of Device Problem 4 4
Device Operational Issue 3 3
Off-Label Use 3 3
Device Contamination with Chemical or Other Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Contamination 2 2
Failure to Power Up 2 2
Component Missing 2 2
Patient-Device Incompatibility 2 2
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Out-Of-Box Failure 1 1
Obstruction of Flow 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Setup or Prepare 1 1
Air Leak 1 1
Loss of or Failure to Bond 1 1
Complete Blockage 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination /Decontamination Problem 1 1
Device Appears to Trigger Rejection 1 1
Sticking 1 1
Volume Accuracy Problem 1 1
Failure to Advance 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 57 57
Cerebrospinal Fluid Leakage 54 54
Unspecified Infection 15 15
No Known Impact Or Consequence To Patient 14 14
Meningitis 12 12
Injury 9 9
Inflammation 8 8
Fever 7 7
No Code Available 7 7
No Patient Involvement 6 6
Swelling 6 6
Pain 5 5
Purulent Discharge 5 5
Bacterial Infection 3 3
Hydrocephalus 3 3
No Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Organ Dehiscence 2 2
Ambulation Difficulties 2 2
Post Operative Wound Infection 2 2
Infarction, Cerebral 2 2
Eye Injury 2 2
Fistula 2 2
Headache 2 2
Visual Impairment 2 2
Vomiting 1 1
Paralysis 1 1
Anaphylactic Shock 1 1
Reaction 1 1
Nerve Damage 1 1
Facial Nerve Paralysis 1 1
Death 1 1
Confusion/ Disorientation 1 1
Nervous System Injury 1 1
Paresthesia 1 1
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1
Fungal Infection 1 1
Spinal Cord Injury 1 1
Neurological Deficit/Dysfunction 1 1
Paresis 1 1
Staphylococcus Aureus 1 1
Spinal Column Injury 1 1
Dry Eye(s) 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Aneurysm 1 1

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