OT ULTRA TEST STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-26 for OT ULTRA TEST STRIPS manufactured by Lifescan Europe Gmbh.

MAUDE Entry Details

Report Number3008382007-2019-03515
MDR Report Key8929425
Report SourceCONSUMER
Date Received2019-08-26
Date of Report2019-08-01
Date Mfgr Received2019-08-01
Date Added to Maude2019-08-26
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 ContactOYINKAN DONALDSON
Manufacturer StreetGUBELSTRASSE 34
Manufacturer CityZUG 6300
Manufacturer CountrySZ
Manufacturer Postal6300
Manufacturer G1LIFESCAN EUROPE GMBH
Manufacturer StreetGUBELSTRASSE 34
Manufacturer CityZUG 6300
Manufacturer CountrySZ
Manufacturer Postal Code6300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOT ULTRA TEST STRIPS
Generic NameGLUCOSE MONITORING SYS/KIT
Product CodeCGA
Date Received2019-08-26
Returned To Mfg2019-04-19
Lot Number4369481
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLIFESCAN EUROPE GMBH
Manufacturer AddressGUBELSTRASSE 34 ZUG 6300 SZ 6300


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-26

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