81104 81104RR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-14 for 81104 81104RR manufactured by Stryker Sustainability Solutions Phoenix.

MAUDE Entry Details

Report Number0002090040-2019-00019
MDR Report Key8700410
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-14
Date of Report2019-06-14
Date of Event2019-04-11
Date Mfgr Received2019-05-28
Device Manufacturer Date2019-01-29
Date Added to Maude2019-06-14
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 ContactMR. MARISSA RICHMOND
Manufacturer Street1810 W. DRAKE DRIVE
Manufacturer CityTEMPE AZ 85283
Manufacturer CountryUS
Manufacturer Postal85283
Manufacturer Phone8888883433
Manufacturer G1STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Manufacturer Street10232 S. 51ST ST.
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal Code85044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameCATHETER, RECORDING, ELECTRODE, REPROCESSED
Product CodeNLH
Date Received2019-06-14
Returned To Mfg2019-04-25
Model Number81104
Catalog Number81104RR
Lot Number3801745
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Manufacturer Address10232 S. 51ST ST. PHOENIX AZ 85044 US 85044


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-14

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