DRIVE 12044

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-27 for DRIVE 12044 manufactured by Foshan Nanhai R. Poon Medical Products (mingguang).

MAUDE Entry Details

Report Number2438477-2019-00077
MDR Report Key9385082
Date Received2019-11-27
Date of Report2019-11-27
Date of Event2019-09-26
Date Facility Aware2019-09-27
Report Date2019-11-27
Date Reported to FDA2019-11-27
Date Reported to Mfgr2019-11-27
Date Added to Maude2019-11-27
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 NameDRIVE
Generic NameTUB RAIL
Product CodeILS
Date Received2019-11-27
Model Number12044
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age5 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerFOSHAN NANHAI R. POON MEDICAL PRODUCTS (MINGGUANG)
Manufacturer AddressNEW CITY DISTRICT DANZAO NANHAI FOSHAN, CH


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-27

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