MAUDE Adverse Event Report: HEALTHIUM MEDTECH PVT. LTD. RELI REDIGUT CHROMIC SUTURE; CHROMIC GUT SUTURE

Catalog Number	GC6354-BRC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an oral surgery, the suture needle detached from the suture.The needle was reported to have detached from several sutures used by the clinician.There was no harm caused to the patient in these instances and the needle was retrieved without issue.

• Brand Name: RELI REDIGUT CHROMIC SUTURE
• Common Device Name: CHROMIC GUT SUTURE
• Manufacturer (Section D): HEALTHIUM MEDTECH PVT. LTD.; 472 d, 13th cross, 4th phase; peenya industrial area; bangalore, karnataka 56005 8; IN 560058
• MDR Report Key: 8292961
• Report Number: 1058382-2019-00001
• Device Sequence Number: 2141763
• Product Code: GAL
• UDI-Device Identifier: 00386120005379
• UDI-Public: 00386120005379
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2019
• Report Date (Section F): 01/31/2019

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: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: GC6354-BRC
• Device Lot Number: MY80710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2019
• Event Location: Other
• Date Report to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2019
• 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: 01/31/2019