ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222B

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 2019-09-16 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222B manufactured by Lake Region Medical.

MAUDE Entry Details

Report Number2126666-2019-00064
MDR Report Key9072109
Report SourceDISTRIBUTOR
Date Received2019-09-16
Date of Report2019-09-16
Date of Event2019-08-05
Date Mfgr Received2019-09-05
Device Manufacturer Date2019-03-08
Date Added to Maude2019-09-16
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 ContactSHARON SEIFERT
Manufacturer Street340 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal55318
Manufacturer Phone9526418518
Manufacturer G1LAKE REGION MEDICAL
Manufacturer Street340 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZIPWIRE HYDROPHILIC GUIDEWIRE
Generic NameUROLOGICAL CATHETER AND ACCESSORIES
Product CodeEZB
Date Received2019-09-16
Model NumberM006630222B1
Catalog Number630-222B
Lot Number11130661
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLAKE REGION MEDICAL
Manufacturer Address340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-16

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