DESIGN OPTIONS 560533

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for DESIGN OPTIONS 560533 manufactured by B. Braun Medical Inc..

MAUDE Entry Details

Report Number9102772
MDR Report Key9102772
Date Received2019-09-23
Date of Report2019-09-17
Date of Event2019-02-25
Report Date2019-09-17
Date Reported to FDA2019-09-17
Date Reported to Mfgr2019-09-23
Date Added to Maude2019-09-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDESIGN OPTIONS
Generic NameSPINAL ANESTHESIA KIT
Product CodeOFU
Date Received2019-09-23
Model Number560533
Catalog Number560533
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD ALLENTOWN PA 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-09-23

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