CRYOMATIC

MAUDE Adverse Event Report

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 .

Event Text Entries

[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


MAUDE Entry Details

Report Number1000391004-2015-00001
MDR Report Key5273434
Report SourceOTHER
Date Received2015-11-06
Date Mfgr Received2015-10-06
Device Manufacturer Date2009-09-01
Date Added to Maude2015-12-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer StreetCLEWER HILL RD.
Manufacturer CityWINDSOR SL4 4AA
Manufacturer CountryUK
Manufacturer PostalSL4 4AA
Manufacturer Phone753827153
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCRYOMATIC
Product CodeHRN
Date Received2015-11-06
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-06

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