PROBASICS BSFC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for PROBASICS BSFC manufactured by Ningbo South Industrial Co., Ltd.

Event Text Entries

[187260374] Patient got her leg tangled up in leg of commode causing her to fall sustaining a fracture of her pelvis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012316249-2020-00001
MDR Report Key9552795
Date Received2020-01-06
Date of Report2020-01-06
Date of Event2019-11-22
Date Facility Aware2019-12-11
Report Date2020-01-06
Date Reported to FDA2020-01-06
Date Reported to Mfgr2020-01-06
Date Added to Maude2020-01-06
Event Key0
Report Source CodeDistributor 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 NamePROBASICS
Generic NameFOLDING 3-IN-1 COMMODE
Product CodeILS
Date Received2020-01-06
Model NumberBSFC
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNINGBO SOUTH INDUSTRIAL CO., LTD
Manufacturer AddressFENGCHENG VILLAGE, JISHIGANG T YINZHOU NINGBO ZHEJIANG, CHINA 315171 CH 315171


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-06

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