MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-06 for CRYOMATIC manufactured by .
[33020550]
The device has not been evaluated as it was returned to the manufacturer only two days ago. A full investigation started immediately upon receipt of the device, but no results of investigation are available as of 10/28/2015. Results of investigation will be submitted in the supplementary report.
Patient Sequence No: 1, Text Type: N, H10
[33020551]
Reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000391004-2015-00001 |
| MDR Report Key | 5273434 |
| Report Source | OTHER |
| Date Received | 2015-11-06 |
| Date Mfgr Received | 2015-10-06 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2015-12-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | CLEWER HILL RD. |
| Manufacturer City | WINDSOR SL4 4AA |
| Manufacturer Country | UK |
| Manufacturer Postal | SL4 4AA |
| Manufacturer Phone | 753827153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOMATIC |
| Product Code | HRN |
| Date Received | 2015-11-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-06 |