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 2001-05-09 for MIRAGEL UNK manufactured by Mira, Inc..

Event Text Entries

[207677] Miragel was episclerally removed by the dr. There were four patients in the past two months. The age of the device is approximately ten years old. There was no injury to the eye, the fourth patient experienced some degree of discomfort, however, the dr stated miragel was not the cause for this.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218813-2001-00001
MDR Report Key332486
Report Source05
Date Received2001-05-09
Date of Report2001-04-30
Date of Event2001-04-19
Date Mfgr Received2001-04-19
Date Added to Maude2001-05-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactMR. STEVE TAMSETT
Manufacturer Street414 QUAKER HIGHWAY
Manufacturer CityUXBRIDGE MA 01569
Manufacturer CountryUS
Manufacturer Postal01569
Manufacturer Phone5082787877
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRAGEL
Generic NameSCLERAL BUCKLING COMPONENT
Product CodeHQJ
Date Received2001-05-09
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedM
Device Sequence No1
Device Event Key321849
ManufacturerMIRA, INC.
Manufacturer Address414 QUAKER HIGHWAY UXBRIDGE MA 01569 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-05-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.