MAUDE Adverse Event Report: FOOSIN MEDICAL SUPPLIES INC., LTD UNIFY; SURGICAL SUTURE

Model Number	L-E230R24
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterility test of the retained sample products are all qualified.The product importer sold this batch of products to different regions or clinics, and only this clinic report this problem.During the communication process, the clinic cannot provide accurate surgery, product information,patients information or return any remained product.
Event or Problem Description
7 patient returned clinic with infection issue after the mini-facelift surgery, and all they used polyester 2/0 suture with the same lot.Per nurse who works in that clinic description, the infection occurred at different time within the first several weeks.Some patients need to reopen and remove the suture.The clinic treated the patients with antibiotics, and they began to heal.

• Brand Name: UNIFY
• Common Device Name: SURGICAL SUTURE
• Manufacturer (Section D): FOOSIN MEDICAL SUPPLIES INC., LTD; no.20, xingshan road weihai; torch hi-tech science park; weihai, shandong province ; CH
• MDR Report Key: 12126288
• Report Number: 3004496829-2021-00009
• Device Sequence Number: 11883912
• Product Code: GAP
• UDI-Device Identifier: 00814639021141
• UDI-Public: 00814639021141
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: Lay User/Patient
• Device Expiration Date: 11/18/2025
• Device Model Number: L-E230R24
• Device Lot Number: YE01239-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NONE
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention