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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sealant, microbial
Definition Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.
Product CodeNZP
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHEZION BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ADHEZION BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADHEZION BIOMEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 1 1
2021 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Packaging Compromised 2 2
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Failure To Adhere Or Bond 1 1
Positioning Failure 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 3 3
Insufficient Information 3 3
Skin Tears 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Eye Pain 1 1

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