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 |