NEOTRACT UROLIFT SYSTEM UL400 AN00155

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for NEOTRACT UROLIFT SYSTEM UL400 AN00155 manufactured by Neotract, Inc..

Event Text Entries

[189024833] On (b)(6) 2019, neotract was made aware of an (b)(6) that underwent a successful prostatic urethral lift (pul) procedure on (b)(6) 2019. In addition, the patient received bilateral ureteral washings, ureteral biopsy, upper pole urothelial biopsy, and bilateral stents. Prior to the pul, the patient had a past medical history of non-muscle invasive bladder cancer, atrial fibrillation, bph, and had a urine culture (b)(6) for (b)(6). At least 4 weeks prior to the procedure, he was treated with ampicillin. While in the recovery room, the patient developed tachycardia and hematuria but was overall reported to be in stable condition. The anesthesiologist stated that the patient has experienced tachycardia after awakening from anesthesia in previous procedures and was not concerned with the patient? S clinical condition. At an undetermined time later, the patient was admitted to the hospital with blood cultures positive for bacteremia and negative urine cultures. During hospitalization, the patient received iv antibiotics and did not receive any additional interventions. It was reported that the hematuria cleared two days post procedure. At an undetermined time later, the bacteremia developed into sepsis. The physician reported that the patient was admitted to the icu for at least twenty-four hours and was hospitalized for six days. He was discharged with an oral course of ampicillin for nine days. At a two week follow up, the physician reported that the patient was recovering and only complained of fatigue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005791775-2020-00003
MDR Report Key9570807
Date Received2020-01-09
Date of Report2020-01-09
Date of Event2019-11-26
Date Mfgr Received2019-12-10
Date Added to Maude2020-01-09
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 ContactMR. BRIAN GALL
Manufacturer Street4155 HOPYARD RD
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone9253296547
Manufacturer G1NEOTRACT, INC.
Manufacturer Street4155 HOPYARD RD
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal Code94588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEOTRACT UROLIFT SYSTEM UL400
Generic NameUROLIFT SYSTEM
Product CodePEW
Date Received2020-01-09
Model NumberUL400
Catalog NumberAN00155
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNEOTRACT, INC.
Manufacturer Address4155 HOPYARD RD PLEASANTON CA 95488 US 95488


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-01-09

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