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 2017-04-21 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..

Event Text Entries

[73447984] A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[73447985] A patient reported they think they may have a urinary tract infection (uti) because they had been going to the bathroom a little frequently and they get a little stab feeling. The patient had not talked to their healthcare provider (hcp) at the time of the report, but would be following up with them on the thursday following the report.
Patient Sequence No: 1, Text Type: D, B5


[75850466] A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[75850467] Additional information from the patient reported that the patient was on antibiotics and still had not gotten the uti test results back. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5


[107236160] 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 Number3012165443-2017-00015
MDR Report Key6513376
Report SourceCONSUMER
Date Received2017-04-21
Date of Report2017-05-24
Date Mfgr Received2017-05-16
Date Added to Maude2017-04-21
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 WOODWARD 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 Received2017-04-21
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 2017-04-21

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