RELI GC636-BRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386120005676), received between Sep 13, 2016 and Jun 9, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2017Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE CHROMIC GUT SUTURE IS LASTING 14 PLUS DAYS IN PATIENT'S MOUTH CAUSED GINGIVAL INFLAMMATION AND IRRITATION (VIA COLLECTING FOOD AND BACTERIA). PATIENTS UNDERWENT EXTRACTION OF THE INITIAL SUTURE AND WERE PLACED ON ANTIBIOTICS AFTER SURGERY AS A PRECAUTION AS THEY DO WITH ALL SURGERY PATIENTS.

  Patient problems: Inflammation

  MAUDE report 6630129 ↗
• InjuryFeb 8, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENTS ARE RETURNING 3 TO 5 WEEKS AFTER SURGERY WITH RED, SWOLLEN GUMS. INFECTION WAS STATED ON THE INITIAL REPORT BUT IT IS NOT CLEAR IF INFECTION WAS CONFIRMED OR IF THE PATIENT WAS TREATED FOR INFECTION. SUTURES WERE REMOVED AND REPLACED WITH OTHER SUTURES. NO ADDITIONAL INFORMATION HAS BEEN AVAILABLE FROM THE END-USER FACILITY AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION OR DETAILS BECOME AVAILABLE, WE WILL UPDATE THIS REPORT.

  Patient problems: Inflammation

  MAUDE report 6310229 ↗
• MalfunctionSep 13, 2016Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE THE CLINICIAN WAS PERFORMING A WISDOM TOOTH EXTRACTION PROCEDURE, THE SUTURE NEEDLE DETACHED FROM THE SUTURE AND FELL ONTO THE PATIENT'S TONGUE. THE DETACHMENT HAPPENED WHEN THE DOCTOR WAS REPOSITIONING THE NEEDLE ON THE DRIVER AFTER PASSING THE NEEDLE THROUGH THE TISSUE. THE PATIENT WAS UNDER SEDATION AND HAD A THROAT PACK AT THE TIME OF THE INCIDENT. THE NEEDLE WAS QUICKLY RECOVERED AND FROM THE PATIENT'S TONGUE. NO HARM CAME TO THE PATIENT AND THERE WERE NO ADVERSE EFFECTS DUE TO THE NEEDLE DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5948103 ↗