BARDEX? MALECOT MODEL DRAIN 086034

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-03 for BARDEX? MALECOT MODEL DRAIN 086034 manufactured by C. R. Bard, Inc..

MAUDE Entry Details

Report Number8662376
MDR Report Key8662376
Date Received2019-06-03
Date of Report2019-05-07
Date of Event2019-04-27
Report Date2019-05-16
Date Reported to FDA2019-05-16
Date Reported to Mfgr2019-06-03
Date Added to Maude2019-06-03
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 NameBARDEX? MALECOT MODEL DRAIN
Generic NameCATHETER, MALECOT
Product CodeFEW
Date Received2019-06-03
Model Number086034
Catalog Number086034
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerC. R. BARD, INC.
Manufacturer Address8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-06-03

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