MIRAGEL UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-08 for MIRAGEL UNK manufactured by Mira Inc.

Event Text Entries

[166871] Md reporting that pt had "symptoms" due to large mass that migrated forward after a previous implantation. All material was removed from eye and pt has been comfortable post surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1218813-2000-00002
• MDR Report Key: 289071
• Report Source: 05
• Date Received: 2000-08-08
• Date of Report: 2000-08-08
• Date of Event: 2000-07-01
• Date Mfgr Received: 2000-08-02
• Date Added to Maude: 2000-08-11
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: R OBRIEN
• Manufacturer Street: 87 RUMFORD AVE
• Manufacturer City: WALTHAM MA 02454
• Manufacturer Country: US
• Manufacturer Postal: 02454
• Manufacturer Phone: 7818942200
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIRAGEL
• Generic Name: SCLERAL BUCKLING COMPONENT
• Product Code: HQJ
• Date Received: 2000-08-08
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 279745
• Manufacturer: MIRA INC
• Manufacturer Address: 87 RUMFORD AVENUE WALTHAM MA 02454 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-08-08