CARDIAC CATH PACK (CBCHQ)840 SAN11CBCHR

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 2020-03-18 for CARDIAC CATH PACK (CBCHQ)840 SAN11CBCHR manufactured by Mex03 Mexico-juarez Presource.

MAUDE Entry Details

Report Number1423537-2020-00437
MDR Report Key9847318
Report SourceUSER FACILITY
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2020-01-03
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1MEX03 MEXICO-JUAREZ PRESOURCE
Manufacturer StreetC. ARCADIA 1580 , COL. TERRAZA
Manufacturer CityCD.JUAREZ , CHIHUAHUA CP 32599
Manufacturer CountryMX
Manufacturer Postal CodeCP 32599
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDIAC CATH PACK (CBCHQ)840
Generic NameGENERAL SURGERY TRAY (KIT)
Product CodeLRO
Date Received2020-03-18
Model NumberSAN11CBCHR
Catalog NumberSAN11CBCHR
Lot Number369759
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEX03 MEXICO-JUAREZ PRESOURCE
Manufacturer AddressC. ARCADIA 1580 , COL. TERRAZA CD.JUAREZ , CHIHUAHUA CP 32599 MX CP 32599


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-18

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