• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TSCI BV DBA THE 37COMPANY PREM FULL UNDERBODY BOX OF 40 SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePREM FULL UNDERBODY BOX OF 40
Type of DeviceSYSTEM, 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 Key10511105
MDR Text Key206297136
Report Number0001831750-2020-00900
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171234
Number of Events Reported1
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 Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMA3400-PM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2020
Distributor Facility Aware Date08/12/2020
Event Location No Information
Date Report to Manufacturer09/09/2020
Date Manufacturer Received08/12/2020
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
-
-