CARDIAC CATH PACK 89-7420

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 2019-07-17 for CARDIAC CATH PACK 89-7420 manufactured by Deroyal Industries, Inc..

MAUDE Entry Details

Report Number3005011024-2019-00008
MDR Report Key8800068
Report SourceUSER FACILITY
Date Received2019-07-17
Date of Report2019-09-09
Date of Event2019-06-04
Date Mfgr Received2019-06-17
Date Added to Maude2019-07-17
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 ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1501 EAST CENTRAL AVENUE
Manufacturer CityLAFOLLETTE TN 37766
Manufacturer CountryUS
Manufacturer Postal Code37766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDIAC CATH PACK
Generic NameANGIOGRAPHY/ANGIOPLASTY KIT
Product CodeOEQ
Date Received2019-07-17
Returned To Mfg2019-07-02
Model Number89-7420
Lot Number49330393
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.