MAUDE Adverse Event Report: MALYUGIN RING; IRIS CLIP RETRACTOR

Model Number	MAL-0002-1
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The facility reported that the malyugin ring stuck on the iris and caused bleeding.

• Brand Name: MALYUGIN RING
• Common Device Name: IRIS CLIP RETRACTOR
• MDR Report Key: 11034613
• Report Number: 3019924-2020-00006
• Device Sequence Number: 1034655
• Product Code: HOC
• UDI-Device Identifier: 00844685000043
• UDI-Public: 00844685000043
• 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: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 07/13/2023
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Device Lot Number: 129280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other