HALYARD 42216NS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-21 for HALYARD 42216NS manufactured by La Ada De Acuna, S. De. R. L. De C. V..

MAUDE Entry Details

Report Number1047429-2019-00011
MDR Report Key8627707
Report SourceUSER FACILITY
Date Received2019-05-21
Date of Report2019-05-21
Date of Event2019-04-23
Date Mfgr Received2019-04-26
Date Added to Maude2019-05-21
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. NICHOLE EARLY
Manufacturer Street9000 WESTMONT DR. STONEHOUSE COMMERCE PARK
Manufacturer CityTOANO VA 23168
Manufacturer CountryUS
Manufacturer Postal23168
Manufacturer Phone8283387568
Manufacturer G1AVID MEDICAL, INC.
Manufacturer Street9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK
Manufacturer CityTOANO VA 23168
Manufacturer CountryUS
Manufacturer Postal Code23168
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHALYARD
Generic NameDRAPE
Product CodePUI
Date Received2019-05-21
Model Number42216NS
Lot NumberAC9029081
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerLA ADA DE ACUNA, S. DE. R. L. DE C. V.
Manufacturer AddressAV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO COL.EDUCATIVA, 84093 MX 84093


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-21

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