MIRA CR4060 OPHTHALMIC CRYO PROBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-16 for MIRA CR4060 OPHTHALMIC CRYO PROBE manufactured by Mira, Inc..

Event Text Entries

[22093334] Probe was part of recall. Probe found to be leaking at the tip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218813-2010-00027
MDR Report Key2022540
Report Source06
Date Received2011-02-16
Date of Report2011-02-11
Date of Event2010-07-14
Date Mfgr Received2010-07-14
Device Manufacturer Date2006-05-01
Date Added to Maude2012-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street414 QUAKER HIGHWAY
Manufacturer CityUXBRIDGE MA 01527
Manufacturer CountryUS
Manufacturer Postal01527
Manufacturer Phone5082787877
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRA CR4060 OPHTHALMIC CRYO PROBE
Product CodeHPS
Date Received2011-02-16
Model NumberCR4060
Catalog NumberCR4060
Lot Number0506
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMIRA, INC.
Manufacturer AddressUXBRIDGE MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-02-16

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