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.

• 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
• Manufacturer (Section G): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• 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
• Reporter Country Code: US
• PMA/PMN Number: K171234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• 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

• Device Catalogue Number: MA3400-PM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Distributor Facility Aware Date: 08/12/2020
• Event Location: No Information
• Date Report to Manufacturer: 09/09/2020
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/09/2020 Patient Sequence Number: 1