MAUDE Adverse Event Report: NULL

Device Problem Excessive Heating (4030)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that while using the warming blanket during long surgery on the patient's upper extremities, the patient experienced second degree burns, blisters, and redness on the neck and thorax, chest area, clavicular area, and deltoids. The warming blanket was on 40 c, a standard medium temperature for these procedures. Electro-medicine department at the reporters facility evaluated it and confirmed it works correctly.

Manufacturer Narrative

The device was unable to be evaluated as it was not returned due to being discarded. The reported event was unable to be confirmed or replicated. A cause of the reported event could not be determined at this time. A dhr review was unable to be completed as no lot information was provided.

• Manufacturer (Section G): NULL
• MDR Report Key: 13825841
• MDR Text Key: 287575869
• Report Number: 3012307300-2022-04722
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No