FISHER-SURE-VUE HCG-STAT SRM/URINE (30T) FHC-A202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-12-20 for FISHER-SURE-VUE HCG-STAT SRM/URINE (30T) FHC-A202 manufactured by Alere San Diego, Inc..

MAUDE Entry Details

Report Number2027969-2019-00616
MDR Report Key9500817
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-12-20
Date of Report2020-02-04
Date of Event2019-12-06
Date Mfgr Received2020-02-03
Date Added to Maude2019-12-20
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 ContactMONIKA BURRELL
Manufacturer Street9975 SUMMERS RIDGE RD.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052506
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFISHER-SURE-VUE HCG-STAT SRM/URINE (30T)
Generic NamePREGNANCY TEST
Product CodeJHI
Date Received2019-12-20
Returned To Mfg2020-01-13
Model NumberFHC-A202
Lot NumberHCG9050160
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC.
Manufacturer Address9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-20

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