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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADHEZION BIOMEDICAL, LLC SURGISEAL TOPICAL SKIN ADHESIVE
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ADHEZION BIOMEDICAL, LLC SURGISEAL TOPICAL SKIN ADHESIVE Back to Search Results
Model Number SS-050S
Medical Device Problem Codes Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Wound Infection (2447)
Date of Event 07/20/2016
Additional Manufacturer Narrative
Mdr being filed 1/2017 as a result of management change and a review of complaints previously determined to be non-reportable, now determined to be reportable.Device not returned to the manufacturer.
 
Event or Problem Description
"a sales representative mentioned that a material manager reported, that a patient had an infection and the wound opened up on using surgiseal stylus.".
 
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Brand Name
SURGISEAL TOPICAL SKIN ADHESIVE
Common Device Name
TOPICAL SKIN ADHESIVE
Manufacturer (Section D)
ADHEZION BIOMEDICAL, LLC
506 pine mountain road
hudson NC 28638
MDR Report Key6291711
Report Number3006385287-2017-00001
Device Sequence Number11153929
Product Code MPN
UDI-Device IdentifierM495SS050S1
UDI-PublicM495SS050S1
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K130474
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Model NumberSS-050S
Device Catalogue NumberSS-050S
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2016
Initial Report FDA Received Date01/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age40 YR
Patient Weight79
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