MAUDE Adverse Event Report: THERMOTEK INC VASCUTHERM 5 THERAPY DEVICE; VT5

Model Number VT5

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Dme reported that patient had post-surgical complications.

• Brand Name: VASCUTHERM 5 THERAPY DEVICE
• Type of Device: VT5
• Manufacturer (Section D): THERMOTEK INC; 1200 lakeside parkway #200; flower mound TX 75028
• Manufacturer (Section G): THERMOTEK INC; 1200 lakeside parkway #200; flower mound TX 75028
• Manufacturer Contact: sara lee ; 1200 lakeside parkway #200; flower mound, TX 75028 ; 9728744949
• MDR Report Key: 11615829
• MDR Text Key: 243909292
• Report Number: 1648700-2020-00001
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: VT5
• Device Catalogue Number: 0P9PTVT500
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 17 YR