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

Catalog Number MA2400-PM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was disposed of by the customer.The patient received ointment and dressings which were applied while in the hospital.

Event Description

It was alleged that during a posterior spinal fusion the patient was burned.Upon further communication with the customer it was identified that the alleged injury is likely pressure injury and not a burn.The customer also confirmed that the pressure injury is likely due to the customers lack of positioning the patient correctly on the under body blanket during the 7 hour posterior spinal fusion.

• Brand Name: FULL UNDERBODY PLUS 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: 12182187
• MDR Text Key: 261988399
• Report Number: 3003312341-2021-00007
• 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: Other
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MA2400-PM
• Device Lot Number: 17563
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other