TissuGlu Surgical Adhesive TG100USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M690TG100US0), received between Feb 8, 2017 and Jun 12, 2017 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 PATIENT'S SURGEON CONDUCTED AN ADDITIONAL SURGICAL PROCEDURE TO CLEAN AND CLOSE AN ABDOMINAL POCKET CONTAINING FLUID. IT WAS REPORTED THAT DURING THIS PROCEDURE PIECES OF UNCURED TISSUGLU® SURGICAL ADHESIVE WERE FOUND IN POTENTIALLY INFECTED ENCAPSULATED SEROMA TISSUE. DR (B)(6) SURGICALLY REMOVED AND CLEANED THE WOUND AND PLACED A DRAIN. THE DRAIN WAS SUBSEQUENTLY REMOVED AND NO FURTHER ISSUES REPORTED. IT WAS FURTHER REPORTED THAT ON (B)(6), THE PATIENT PRESENTED WITH FLUID DEVELOPMENT IN A DIFFERENT AREA OF THE ABDOMEN. THE DOCTOR REPORTEDLY ASPIRATED THE FLUID FROM THIS AREA TWO SEPARATE TIMES WITHOUT RESOLUTION AND DECIDED TO PERFORM AN ADDITIONAL REVISION SURGICAL PROCEDURE. THE HEALTHCARE PROFESSIONAL RESPONSIBLE FOR THE PATIENT'S CARE ALLEGES THE COMPLICATIONS TO BE ASSOCIATED WITH THE USE OF TISSGLU SURGICAL ADHESIVE. THE REPORTED FLUID DEVELOPMENT AND PRESENCE OF TISSUGLU® SURGICAL ADHESIVE FRAGMENTS IS CONSISTENT WITH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED

  Patient problems: Discharge

  MAUDE report 6635620 ↗
• InjuryFeb 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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.

  Patient problems: Discharge

  MAUDE report 6312754 ↗