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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL

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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.
 
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Manufacturer (Section G)
NULL
MDR Report Key13825841
MDR Text Key287575869
Report Number3012307300-2022-04722
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
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 Received03/19/2022
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

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