MAUDE Adverse Event Report: THERMOTEK, INC. VASCUTHERM4 THERAPY DEVICE; VT4

Model Number VT4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation and no information was given other than dme wanted to know if compliance was retrievable for device and that they wanted to know in response to an adverse event, but no details of event were given and no information about device, other than model, was supplied to the mfg.

Event Description

Distributor called and wanted to know if there was a way to track compliance on the vt4; sales advised the caller they would need to check what was retrievable; they also asked if this was a general question or related to an adverse event.Distributor responded it ws to an adverse event.Sales forwarded email to quality; quality emailed distributor and advised to fill our an alleged patient injury form and contact customer service for an rma so that the device could be returned and evaluated.Distributor responded that they only wanted an answer to their question and did not want to return the device.Advised customer it was in every ones best interest to have the device evaluated.Distributor did not respond to multiple requests for feedback or acceptance of evaluation of device free of charge.The last contact made by (b)(4) to the distributor was (b)(6) 2019 and they responded that they haven't heard anything more from the doctor about the patient or incident.Will follow up with a supplemental report if additional information is received.

• Brand Name: VASCUTHERM4 THERAPY DEVICE
• Type of Device: VT4
• 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
• MDR Report Key: 8578147
• MDR Text Key: 144100588
• Report Number: 1648700-2019-00001
• 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: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VT4
• Device Catalogue Number: 0P9PTVT400
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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