MAUDE Adverse Event Report: SUTURES INDIA PVT., LTD. RELI REDGIT CHR; CHROMIC GUT SUTURE

Catalog Number	GC636-BRC
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dentist office representative indicated they expected the chromic gut to absorb within 4-7 days.Chromic gut sutures generally take longer to absorb, so a plain gut suture was recommended which may be better to meet the customer's expectation.Also, it was reported that antibiotics were prescribed as a precaution due to the inflammation, however, there were no reports of infection associated with these events.This report will be updated upon the manufacturer's conclusion of this event.
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: RELI REDGIT CHR
• Common Device Name: CHROMIC GUT SUTURE
• Manufacturer (Section D): SUTURES INDIA PVT., LTD.; 472d, 13th cross, 4th phase; peenya industrial area; bengaluru, 560 0 58; IN 560 058
• MDR Report Key: 6630129
• Report Number: 1058382-2017-00004
• Device Sequence Number: 13657016
• Product Code: GAL
• UDI-Device Identifier: 00386120005676
• UDI-Public: 00386120005676
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017
• Report Date (Section F): 08/11/2017

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: No Information
• Device Catalogue Number: GC636-BRC
• Device Lot Number: MY60014, MY60044, MY52067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2017
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 08/11/2017
• 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; Required Intervention
• Date Report Sent to FDA: 08/11/2017