MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY PREM FULL UNDERBODY BOX OF 40; SYSTEM, THERMAL REGULATING

Catalog Number MA3400-PM

Device Problems No Apparent Adverse Event (3189); Excessive Heating (4030)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Event Description

It was reported that the patient received a burn while using the device.Further information has not been provided at this time.

Manufacturer Narrative

Upon further communication with the user facility, it was stated that there was no issue with the device and that the device did not cause or contribute to the burn to the patient.H3 other text : no device problem occurred.

Event Description

It was alleged that the patient received a burn while using the device.

• Brand Name: PREM FULL UNDERBODY BOX OF 40
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• MDR Report Key: 10511105
• MDR Text Key: 206297136
• Report Number: 0001831750-2020-00900
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K171234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2020,10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MA3400-PM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Distributor Facility Aware Date: 08/12/2020
• Date Report to Manufacturer: 09/09/2020
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other