PJUR ORIGINAL D223925

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 2019-04-23 for PJUR ORIGINAL D223925 manufactured by Pjur Group Luxembourg S.a..

Event Text Entries

[142736043] Suspected product was not returned for analysis. Analysis of retained samples showed product was within specification and no microbial contamination was found. Review of the production records showed no anomaly. No similar complaints have been received in this product line.
Patient Sequence No: 1, Text Type: N, H10


[142736044] User reported irritation and kidney, yeast, and bacterial infections that started several days after use of pjur original personal lubricant. User reported visiting doctor 4-5 times for tests.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007957048-2019-00001
MDR Report Key8539044
Report SourceCONSUMER
Date Received2019-04-23
Date of Report2018-12-10
Date of Event2018-12-01
Device Manufacturer Date2016-07-18
Date Added to Maude2019-04-23
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 ContactMRS. ANDREA GIEBEL
Manufacturer Street87, ESPLANADE DE LA MOSELLE
Manufacturer CityWASSERBILLIG, 6637
Manufacturer CountryLU
Manufacturer Postal6637
Manufacturer G1PJUR GROUP LUXEMBOURG S.A.
Manufacturer Street87, ESPLANADE DE LA MOSELLE
Manufacturer CityWASSERBILLIG, 6637
Manufacturer CountryLU
Manufacturer Postal Code6637
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePJUR ORIGINAL
Generic NamePERSONAL LUBRICANT
Product CodeNUC
Date Received2019-04-23
Model NumberD223925
Lot Number31880-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPJUR GROUP LUXEMBOURG S.A.
Manufacturer Address87, ESPLANADE DE LA MOSELLE WASSERBILLIG, 6637 LU 6637


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-23

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