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 2001-05-10 for MIRAGEL UNK manufactured by Mira, Inc..

Event Text Entries

[189037] Removal of miragel, unknown lot no. Or style, and no pt info provided. Pt "globe" became immobile due to expansion of miragel implant was "jellie-like" and "fryable". No occular injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1218813-2001-00002
• MDR Report Key: 332815
• Report Source: 05
• Date Received: 2001-05-10
• Date of Report: 2001-04-27
• Date of Event: 2001-04-19
• Date Mfgr Received: 2001-04-19
• Date Added to Maude: 2001-05-17
• 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: MR. STEVE TAMSETT
• Manufacturer Street: 414 QUAKER HIGHWAY
• Manufacturer City: UXBRIDGE MA 01569
• Manufacturer Country: US
• Manufacturer Postal: 01569
• Manufacturer Phone: 5082787877
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIRAGEL
• Generic Name: SCLERAL BUCKLING COMPONENT
• Product Code: HQJ
• Date Received: 2001-05-10
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Implant Flag: Y
• Date Removed: M
• Device Sequence No: 1
• Device Event Key: 322186
• Manufacturer: MIRA, INC.
• Manufacturer Address: 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-05-10