MAUDE Adverse Event Report: THERMOTEK, INC VASCUTHERM2 THERAPY DEVICE

Model Number VASCUTHERM2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 04/15/2016

Event Type  Injury  

Event Description

Patient had part of foot amputated after initial foot surgery.Dme spoke with dr.(b)(6) on (b)(6) 2016 and the dr.Reported that the therapy unit was not responsible for the amputation and that the cold wrap was not directly touching the part of the foot that was amputated.Date of event is unknown.Device was programmed for 30 mins.On and 15 mins.Off.Both cold and dvt therapy was prescribed.Dressing was used under the wrap; patient reported using the device for four days before incident.Device was being used at patients home.

• Brand Name: VASCUTHERM2 THERAPY DEVICE
• Type of Device: VASCUTHERM2 THERAPY DEVICE
• 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
• MDR Report Key: 5750952
• MDR Text Key: 48243961
• Report Number: 1648700-2016-00003
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VASCUTHERM2
• Device Catalogue Number: 0P9PTVASCU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• 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): Disability
• Patient Age: 41 YR