MAUDE Adverse Event Report: SM ENG CO.,LTD. UNIFY PREMIUM+ PGA; SURGICAL SUTURE

Model Number	PMGU-418R13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The item user contact our us agent and report that the item seems to cause a inflammatory reaction like erythema on the patient.

• Brand Name: UNIFY PREMIUM+ PGA
• Common Device Name: SURGICAL SUTURE
• Manufacturer (Section D): SM ENG CO.,LTD.; 46 nakdong-daero,1302 beon-gil; sasang-gu; busan, 46910 ; KS 46910
• Manufacturer (Section G): SM ENG CO.,LTD.; 46 nakdong-daero,1302 beon-gil; sasang-gu; busan, 46910 ; KS 46910
• Manufacturer Contact: inhye lee ; 46 nakdong-daero,1302 beon-gil; sasang-gu; busan, 46910 ; KS 46910
• MDR Report Key: 15534761
• Report Number: 3008912461-2022-00001
• Device Sequence Number: 12734539
• Product Code: GAM
• UDI-Device Identifier: 00814639021547
• UDI-Public: 00814639021547
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: PMGU-418R13
• Device Lot Number: 2103US577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White