MAUDE Adverse Event Report: THERMOTEK, INC VASCUTHERM3 THERAPY SYSTEM; COMPRESSION AND TEMPERATURE THERAPY DEVICE

Model Number VASCUTHERM3

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Skin Discoloration (2074); Tissue Damage (2104); Numbness (2415); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 05/20/2013

Event Type  Injury  

Manufacturer Narrative

Device has never been returned for repair; it was sent back once on 9/28/11 for the power supply to be upgraded, but device was operational when returned for upgrade.After upgrade, device was tested and passed all specifications before it was returned to customer.There have been multiple unsuccessful attempts to retrieve the device (from the distributor) and have it returned for analysis.Patient and mother have both testified that the device did not fail during use and operated as specified.There were not any reports that device did not operate as intended and there is no conclusive data or information to suggest the device caused or contributed to the injury.Thermotek was not made aware of any medications the patient may have been prescribed during use of the device.Device was not returned to us.

Event Description

Device was pre-programmed @ 43f degrees to provide cold therapy 45 minutes of every hour.Patient followed instructions given.On (b)(6) three days post surgery, pt toes began to feel numb and turned bluish.Patients mother removed the vascutherm device on (b)(6).On may 18th, a call was placed to the doctors office and reported symptoms to a nurse; the nurse instructed to elevate the foot higher; patient complied.On sunday, patient developed a fever and called the doctors office and was told to come to the office the following day (monday).When patient arrived at doctors office on (b)(6), bubble blisters had begun to develop and she was admitted to the hospital ((b)(6)).From that point forward, patient was hospitalized for a significant period of time, and ultimately underwent a series of surgeries, culminating with partial amputations to toes.There have been multiple unsuccessful attempts to retrieve the device (from the distributor) and have it returned for analysis.Patient and mother have both testified that the device did not fail during use and operated as specified.There were not any reports that device did not operate as intended and there is no conclusive data or information to suggest the device caused or contributed to the injury.Thermotek was not made aware of any medications the patient may have been prescribed during use of the device.

• Brand Name: VASCUTHERM3 THERAPY SYSTEM
• Type of Device: COMPRESSION AND TEMPERATURE 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 ; 9728744949
• MDR Report Key: 5745057
• MDR Text Key: 48092286
• Report Number: 1648700-2016-00002
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VASCUTHERM3
• Device Catalogue Number: 0P9PTVASC3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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: 19 YR