MAUDE Adverse Event Report: COHERA MEDICAL INC TISSUGLU SURGICAL ADHESIVE

Model Number	TG100US
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Discharge (2225)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the company by a healthcare professional that a patient underwent an abdominoplasty surgery using tissuglu surgical adhesive in conjunction with standard of care on (b)(6) 2016.On (b)(6) 2017, the doctor informed cohera that he performed a revision surgery because he observed extrusion of tissuglu® through the incision line.The reported extrusion of tissuglu® surgical adhesive fragments is consistent with known potential complications associated with abdominoplasty surgeries and is described as a precaution in the tissuglu surgical adhesive directions for use (dfu-100-0001): "consideration should be taken in the use of tissuglu®, as there is a possibility that cured tissuglu® may be extruded similar to suture extrusion." it is not anticipated that the existence or expulsion of tissuglu® will present any adverse reaction, infection, or other health consequence associated with the expulsion of the tissuglu® fragments.

• Brand Name: TISSUGLU SURGICAL ADHESIVE
• Common Device Name: TISSUGLU
• Manufacturer (Section D): COHERA MEDICAL INC; 227 fayetteville st; suite 900; raleigh NC 27601
• MDR Report Key: 6312754
• Report Number: 3012970114-2017-00001
• Device Sequence Number: 540042
• Product Code: PJK
• UDI-Device Identifier: M690TG100US0
• UDI-Public: M690TG100US0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: TG100US
• Device Lot Number: CM0332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/08/2017
• 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