MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-11-23 for MIRA CR4000 OPHTHALMIC CRYO UNIT CR4010 manufactured by Mira, Inc..
[21430101]
Excessive leaking from probe tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2010-00017 |
| MDR Report Key | 1910839 |
| Report Source | 06 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-06-22 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2011-02-25 |
| 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 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRA CR4000 OPHTHALMIC CRYO UNIT |
| Product Code | HPS |
| Date Received | 2010-11-23 |
| Model Number | CR4010 |
| Catalog Number | CR4010 |
| Lot Number | 0109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | UXBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-23 |