BLADDER SCANNER BRP-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for BLADDER SCANNER BRP-1 manufactured by Direct Supply Manufacturing Inc..

Event Text Entries

[182212699] Bladder scanner caught on fire while charging. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093543
MDR Report Key9794040
Date Received2020-03-05
Date of Report2020-03-03
Date of Event2020-02-27
Date Added to Maude2020-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLADDER SCANNER
Generic NameTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product CodeITX
Date Received2020-03-05
Model NumberBRP-1
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDIRECT SUPPLY MANUFACTURING INC.
Manufacturer AddressDS71 VAN NUYS CA 91405 US 91405


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.