MALYUGIN RING * MAL-0002-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-15 for MALYUGIN RING * MAL-0002-1 manufactured by Microsurgical Technology, Inc..

Event Text Entries

[3257695] Injector jammed and was discarded prior to use. What was the original intended procedure? Unknown.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3022853
• MDR Report Key: 3022853
• Date Received: 2013-03-15
• Date of Report: 2013-03-11
• Date of Event: 2013-03-07
• Report Date: 2013-03-11
• Date Reported to FDA: 2013-03-15
• Date Reported to Mfgr: 2013-03-27
• Date Added to Maude: 2013-03-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MALYUGIN RING
• Generic Name: HOOK, OPHTHALMIC
• Product Code: HNQ
• Date Received: 2013-03-15
• Model Number: *
• Catalog Number: MAL-0002-1
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICROSURGICAL TECHNOLOGY, INC.
• Manufacturer Address: 8415 15TH AVENUE, NE RICHMOND WA 98052 US 98052

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-03-15