MAUDE Adverse Event Report: CRYOMATIC

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Reference: (b)(4).

• Brand Name: CRYOMATIC
• Manufacturer Contact: clewer hill rd.; windsor SL4 4-AA ; 753827153
• MDR Report Key: 5273434
• MDR Text Key: 33020550
• Report Number: 1000391004-2015-00001
• Device Sequence Number: 1
• Product Code: HRN
• Combination Product (y/n): N
• PMA/PMN Number: K112093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1