MAUDE Adverse Event Report: ADHEZION BIOMEDICAL, LLC SURGISEAL TOPICAL SKIN ADHESIVE; SURGISEAL "TEARDROP"

Model Number	SS035-T
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint originally received on 10/26/2015.Upon review, it was incorrectly determined that the adverse event was not reportable.Upon further review, and to err on the side of safety, it was decided that an mdr should be filed.A physician's office was the initial reporter, and many attempts were made to investigate the alleged event.Upon contact with the reporter, scant information was shared with the manufacturer, and the patient was not available to elaborate or confirm any details.Should any additional details become available, a follow up report will be submitted.
Event or Problem Description
Nurse reported that the patient experienced redness and oozing at the incision site five day after surgery.No other applications were known, by the complainant, to be applied to the patient, and the patient had no known allergies.The complainant does not know the lot number of the material, nor the supplier (distributor) that provided surgiseal.The patient is recovering.

• Brand Name: SURGISEAL TOPICAL SKIN ADHESIVE
• Common Device Name: SURGISEAL "TEARDROP"
• Manufacturer (Section D): ADHEZION BIOMEDICAL, LLC; 506 pine mountain road; hudson NC 28638
• MDR Report Key: 6178716
• Report Number: 3006385287-2015-00006
• Device Sequence Number: 13559617
• Product Code: MPN
• UDI-Device Identifier: M495SS035T1
• UDI-Public: M495SS035T1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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: Physician
• Device Model Number: SS035-T
• Device Catalogue Number: SS035-T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2015
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 91