MAUDE Adverse Event Report: SM ENG UNIFY; ABSORBABLE PGA SUTURES

Model Number	PSGU-418R13
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report received in end april.This is a single accident and sterile reports are all negative and passed.No evident to support the inflammation is pinpointed to the sutures so we did not report to fda.But our consultant visited us in july and recommended us to reopen the complaint and file a mdr even though no other complaint was reported after.
Event or Problem Description
Doctor emailed us about concern of the quality of the premium pga sutures.They seem to consistently cause a very significant inflammatory reaction on her patients.

• Brand Name: UNIFY
• Common Device Name: ABSORBABLE PGA SUTURES
• Manufacturer (Section D): SM ENG; 46 nakdong-daero,; sasang-gu,, busan 46910 ; KS 46910
• MDR Report Key: 15108174
• Report Number: 3002979697-2022-00001
• Device Sequence Number: 11799836
• Product Code: GAM
• UDI-Device Identifier: 00814639021547
• UDI-Public: 00814639021547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022
• Report Date (Section F): 04/26/2022

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: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: PSGU-418R13
• Device Catalogue Number: PSGU-418R13
• Device Lot Number: 2103US577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2022
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2022
• 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
• Patient Sex: Unknown