BALLARD MINI-BAL PREP PACK WITH SPECIMEN TRAP 140 101239301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for BALLARD MINI-BAL PREP PACK WITH SPECIMEN TRAP 140 101239301 manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number3011270181-2019-00034
MDR Report Key9098417
Date Received2019-09-20
Date of Report2019-09-20
Date of Event2019-08-22
Date Mfgr Received2019-08-29
Date Added to Maude2019-09-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVID MEDICAL
Manufacturer Street9000 WESTMONT DR. STONEHOUSE COMMERCE PARK
Manufacturer CityTOANO VA 23168
Manufacturer CountryUS
Manufacturer Postal Code23168
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBALLARD MINI-BAL PREP PACK WITH SPECIMEN TRAP
Generic NameVAP AIRWAY DIAGNOSTICS BAL-CATH
Product CodeMMO
Date Received2019-09-20
Model Number140
Catalog Number101239301
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-20

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