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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIRECT SUPPLY MANUFACTURING INC. BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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DIRECT SUPPLY MANUFACTURING INC. BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number BRP-1
Device Problem Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2020
Event Type  No Answer Provided  
Event Description
Bladder scanner caught on fire while charging. Fda safety report id# (b)(4).
 
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Brand NameBLADDER SCANNER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
DIRECT SUPPLY MANUFACTURING INC.
ds71
van nuys CA 91405
MDR Report Key9794040
MDR Text Key182212699
Report NumberMW5093543
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberBRP-1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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