MAUDE Adverse Event Report: THERMOTEK INC VASCUTHERM5; VASCUTHERM 5

Model Number	0P9PTVT500
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The therapy wrap (foot/ankle wrap) used by the patient was not returned with the device, so we used a new version from inventory of the same model to simulate therapy performed.The prescription provided by the dme did not indicate the modalities that the device and wrap were to be used for therapy.It only indicated to use for 28 days (no temperature or on/off times).The patient agreement was not signed to show that the patient had been instructed in the correct use of the vascutherm unit.The customer requested an rma for the device for leaking; it was after the device had been returned and begun evaluation that the customer called us back and reported the pt issue.We had to retrieve device from the repair dept.And quarentine for evaluation related to suspect pt incident.Device performed as intended during preliminary investigation; further testing requested by engineering.Device is quarentined in quality assurance until further testing can be performed.A follow up report will be made after further testing is completed.
Event or Problem Description
After two days of use, pt complained device was leaking and there is an issue with her foot and hopes its not caused from the vt5.On (b)(6), dme replaced unit with another and no longer experienced any further issues.Dr discontinued use on (b)(6).Even was not reported to manufacturer until (b)(6) 2022.

• Brand Name: VASCUTHERM5
• Common Device Name: VASCUTHERM 5
• 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: 15139869
• Report Number: 1648700-2022-00001
• Device Sequence Number: 15277771
• Product Code: ILO
• UDI-Device Identifier: B5850P9PTVT5000
• UDI-Public: +B5850P9PTVT5000/16D20180601S
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0P9PTVT500
• Device Catalogue Number: 0P9PTVT500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female