NURO 3533

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 2017-02-14 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..

Event Text Entries

[67393616]
Patient Sequence No: 1, Text Type: N, H10


[67393617] A patient reported they think they have a bladder infection. They were experiencing burning sensations when they void. There were no external factors related to the event. There were no diagnostics related to the event. The patient would follow up with their healthcare provider (hcp) and the issue was noted as not being resolved at the time of the report. The patient was being treated with an external ptnm device.
Patient Sequence No: 1, Text Type: D, B5


[110476704] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3012165443-2017-00006
MDR Report Key6329935
Report SourceCONSUMER
Date Received2017-02-14
Date of Report2017-02-14
Date of Event2017-02-10
Date Mfgr Received2017-02-10
Date Added to Maude2017-02-14
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 ContactLISA CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1ADVANCED URO-SOLUTIONS, L.L.C.
Manufacturer Street7842 HICKORY FLAT HIGHWAY SUITE D
Manufacturer CityWOODSTOCK GA 30188
Manufacturer CountryUS
Manufacturer Postal Code30188
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNURO
Generic NameSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
Product CodeNAM
Date Received2017-02-14
Model Number3533
Catalog Number3533
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerADVANCED URO-SOLUTIONS, L.L.C.
Manufacturer Address7842 HICKORY FLAT HIGHWAY SUITE D WOODSTOCK GA 30188 US 30188


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-14

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