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..
[22093334]
Probe was part of recall. Probe found to be leaking at the tip.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1218813-2010-00027 |
MDR Report Key | 2022540 |
Report Source | 06 |
Date Received | 2011-02-16 |
Date of Report | 2011-02-11 |
Date of Event | 2010-07-14 |
Date Mfgr Received | 2010-07-14 |
Device Manufacturer Date | 2006-05-01 |
Date Added to Maude | 2012-01-13 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Street | 414 QUAKER HIGHWAY |
Manufacturer City | UXBRIDGE MA 01527 |
Manufacturer Country | US |
Manufacturer Postal | 01527 |
Manufacturer Phone | 5082787877 |
Single Use | 3 |
Remedial Action | RC |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MIRA CR4060 OPHTHALMIC CRYO PROBE |
Product Code | HPS |
Date Received | 2011-02-16 |
Model Number | CR4060 |
Catalog Number | CR4060 |
Lot Number | 0506 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MIRA, INC. |
Manufacturer Address | UXBRIDGE MA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-02-16 |