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

Catalog Number	GC636-BRC
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: RELI
• Common Device Name: CHROMIC GUT SUTURE
• Manufacturer (Section D): SUTURES INDIA PVT., LTD.; 472d, 13th cross, 4th phase; peenya industrial area; bengaluru, karnataka 560 0 58; IN 560 058
• MDR Report Key: 5948103
• Report Number: 1058382-2016-00002
• Device Sequence Number: 16342024
• Product Code: GAL
• UDI-Device Identifier: 00386120005676
• UDI-Public: 00386120005676
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2016
• Report Date (Section F): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Expiration Date: 10/05/2020
• Device Catalogue Number: GC636-BRC
• Device Lot Number: MY52067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2016
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/13/2016