MAUDE Adverse Event Report: SUTURES INDIA PVT., LTD. RELI; NATURAL ABSORABLE SUTURE

Catalog Number	GC636-BRC
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: RELI
• Common Device Name: NATURAL ABSORABLE 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: 6310229
• Report Number: 1058382-2017-00002
• Device Sequence Number: 13681274
• Product Code: GAL
• UDI-Device Identifier: 10386120005673
• UDI-Public: 10386120005673
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2017
• Report Date (Section F): 07/26/2017

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?: 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: 02/01/2017
• Device Age: 19 MO
• Event Location: Other
• Date Report to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 07/26/2017; 07/26/2017
• 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
• Date Report Sent to FDA: 07/26/2017