MALYUGIN RING SYSTEM MAL-0002-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-10-16 for MALYUGIN RING SYSTEM MAL-0002-1 manufactured by Microsurgical Technology, Inc..

Event Text Entries

[18730171] The surgeon reported that the glue joints separated upon removal of the ring from the eye. There was no impact to the patients.
Patient Sequence No: 1, Text Type: D, B5

[19008675] The results of the returned product evaluation were inconclusive.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3019924-2014-00046
• MDR Report Key: 4269427
• Report Source: 05,08
• Date Received: 2014-10-16
• Date of Report: 2014-10-16
• Date Mfgr Received: 2014-09-19
• Device Manufacturer Date: 2014-07-01
• Date Added to Maude: 2014-11-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 8415 154TH AVE., N.E.
• Manufacturer City: REDMOND WA 98052
• Manufacturer Country: US
• Manufacturer Postal: 98052
• Manufacturer Phone: 4255560544
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MALYUGIN RING SYSTEM
• Generic Name: IRIS CLIP RETRACTOR
• Product Code: HOC
• Date Received: 2014-10-16
• Returned To Mfg: 2014-10-10
• Model Number: MAL-0002-1
• Catalog Number: MAL-0002-1
• Lot Number: 062822
• Device Expiration Date: 2017-07-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICROSURGICAL TECHNOLOGY, INC.
• Manufacturer Address: REDMOND WA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-10-16