SYSTEM JO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-23 for SYSTEM JO manufactured by United Consortium.

Event Text Entries

[68212555] Caused burning and infection to reporter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1032263-2017-00005
MDR Report Key6355139
Date Received2017-02-23
Date of Report2017-02-23
Date Mfgr Received2016-01-19
Date Added to Maude2017-02-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE MORRIS
Manufacturer Street29000 N. HANCOCK PKWY.
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone6612951700
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSYSTEM JO
Generic NamePERSONAL LUBRICANT
Product CodeNUC
Date Received2017-02-23
Lot Number153675
Device Expiration Date2018-06-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNITED CONSORTIUM
Manufacturer Address29000 N. HANCOCK PKWY. VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-02-23

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