MIRAGEL 907 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-10 for MIRAGEL 907 * manufactured by Mira, Inc..

Event Text Entries

[318030] The miragel implant incurred swelling and degradation over the course of several years. Implant was removed and found to be swollen and fragmented. Pt has lost a significant amount of vision in their right eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029528
• MDR Report Key: 486396
• Date Received: 2003-09-20
• Date of Report: 2003-09-02
• Date of Event: 2000-06-28
• Date Added to Maude: 2003-10-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIRAGEL
• Generic Name: SCLERAL BUCKLE IMPLANT
• Product Code: HQJ
• Date Received: 2003-09-10
• Model Number: 907
• Catalog Number: *
• Lot Number: H164
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 475280
• Manufacturer: MIRA, INC.
• Manufacturer Address: 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US
• Baseline Brand Name: MIRAGEL
• Baseline Generic Name: SCLERAL BUCKLING IMPLANT
• Baseline Model No: 907
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: SCLERAL BUCKLING COMPONENTS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K821793
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2003-09-20