INTRAVESICAL ADMINISTRATION KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for INTRAVESICAL ADMINISTRATION KIT manufactured by B. Braun Melsungen Ag.

MAUDE Entry Details

Report NumberMW5087867
MDR Report Key8760464
Date Received2019-07-02
Date of Report2019-06-27
Date of Event2019-06-26
Date Added to Maude2019-07-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINTRAVESICAL ADMINISTRATION KIT
Generic NamePARENTERAL ADMINISTRATION KIT
Product CodePOR
Date Received2019-07-02
Lot NumberS190001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MELSUNGEN AG
Manufacturer AddressMALVERN PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-02

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