LEAD ADAPTOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-29 for LEAD ADAPTOR manufactured by Oscor Inc..

MAUDE Entry Details

Report Number1035166-2019-00061
MDR Report Key8836873
Report SourceDISTRIBUTOR
Date Received2019-07-29
Date of Report2019-07-29
Date of Event2019-06-04
Date Mfgr Received2019-07-01
Date Added to Maude2019-07-29
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 ContactMR DOUG MYERS
Manufacturer Street3816 DESOTO BLVD
Manufacturer CityPALM HABROR FL 34683
Manufacturer CountryUS
Manufacturer Postal34683
Manufacturer Phone7279372511
Manufacturer G1OSCOR INC
Manufacturer Street3816 DESOTO BLVD
Manufacturer CityPALM HARBOR FL 346831816
Manufacturer CountryUS
Manufacturer Postal Code346831816
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD ADAPTOR
Generic NamePACEMAKER LEAD ADAPTOR
Product CodeDTD
Date Received2019-07-29
Lot NumberC4-14020
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOSCOR INC.
Manufacturer Address3816 DESOTO BLVD PALM HARBOR FL 34683 US 34683


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-29

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