SOFTCLIX ? LANCETS 11893238160

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 2020-02-19 for SOFTCLIX ? LANCETS 11893238160 manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[180437832] Product is no longer available to be returned.
Patient Sequence No: 1, Text Type: N, H10


[180437833] It was reported that a fragment of the lancet broke off in the patient's finger. The patient was able to remove the lancet himself. No medical treatment was required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-00656
MDR Report Key9727032
Report SourceCONSUMER
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2012-01-01
Date Mfgr Received2020-02-06
Date Added to Maude2020-02-19
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 ContactNA GREG SMITH
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 462500457
Manufacturer CountryUS
Manufacturer Postal462500457
Manufacturer Phone3175212484
Manufacturer G1FACET TECHNOLOGIES LLC
Manufacturer Street3900 NORTH COMMERCE DRIVE NA
Manufacturer CityATLANTA GA 30344
Manufacturer CountryUS
Manufacturer Postal Code30344
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSOFTCLIX ? LANCETS
Generic NameLANCET
Product CodeFMK
Date Received2020-02-19
Catalog Number11893238160
Lot NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeNULL
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIABETES CARE, INC.
Manufacturer Address9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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