MAUDE Adverse Event Report: THERMOTEK, INC VASCUTHERM2

Model Number VASCUTHERM2

Device Problem Insufficient Information (3190)

Patient Problem Numbness (2415)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Device has not been returned for evaluation at the time of this report.Dme has reported that device was used for cooling therapy with a setting at 43 degrees f for 30 minutes on/30 minutes off.The patient used the device for 5-7 days and was used with a foot/ankle wrap on the right ankle.Dressing was applied under the wrap.A copy of the physicians prescription and patient orientation training was not sent with complaint even though report says they were attached.An email request has been sent to the dme to forward that information for device evaluation.

Event Description

Patient sent an email to the doctor on (b)(6) 2016 asking if the machine should be picked up.In the email, the patient stated she thinks "there is some skin damage to her foot".Doctor emailed on (b)(6) 2016 "we have been seeing the at one week but there have been some issues with maceration".Specifically to the plantar surface of the foot and calcaneus.Patient also complained of numbness to area where the machine tended to concentrate cooling.Medical or surgical intervention to preclude permanent impairment of body function or permanent damage to body was not required.

• Brand Name: VASCUTHERM2
• Type of Device: VASCUTHERM2
• Manufacturer (Section D): THERMOTEK, INC; 1200 lakeside parkway; suite 200; flower mound TX 75028
• Manufacturer (Section G): THERMOTEK, INC; 1200 lakeside parkway; suite 200; flower mound TX 75028
• Manufacturer Contact: sara lee ; 1200 lakeside parkway; suite 200; flower mound, TX 75028 ; 9728744900
• MDR Report Key: 5995236
• MDR Text Key: 56334054
• Report Number: 1648700-2016-00005
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 061866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: VASCUTHERM2
• Device Catalogue Number: 0P9PTVASCU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other