MIRAGEL SPONGE 907 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-04 for MIRAGEL SPONGE 907 * manufactured by Mira, Inc..

Event Text Entries

[21254874] Miragel scleral explant; with swelling, diplopia and restriction of gaze. Removal of miragel sponge in left eye on 11-4-98.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015616
• MDR Report Key: 208902
• Date Received: 1999-02-04
• Date of Report: 1999-01-12
• Date of Event: 1998-11-04
• Date Added to Maude: 1999-02-09
• 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
• 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 SPONGE
• Generic Name: SCLERAL BUCKLE COMPONENT FOR RETINAL DETACHMENT
• Product Code: HQJ
• Date Received: 1999-02-04
• Model Number: 907
• Catalog Number: *
• Lot Number: H254
• ID Number: *
• Device Availability: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 202737
• Manufacturer: MIRA, INC.
• Manufacturer Address: 87 RUMFORD AVE. WALTHAM MA 02454 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. Required No Informationntervention	1999-02-04