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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400
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NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400 Back to Search Results
Model Number UROLIFT SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Event Date 12/02/2019
Event Type  Injury  
Event Description
On 3 dec 2019, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2019.Later that evening, the patient became hypotensive and reported to not have resolved.A ct scan was performed and identified a large extraperitoneal hemorrhage.The patient received a transfusion, and stayed overnight at the icu.It was reported that the patient appears to be recovering.No additional information was available after multiple attempts to contact the physician.
 
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Brand Name
NEOTRACT UROLIFT SYSTEM UL400
Type of Device
UROLIFT SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
4155 hopyard road
pleasanton CA 94588
Manufacturer (Section G)
NEOTRACT, INC.
4155 hopyard road
pleasanton CA 94588
Manufacturer Contact
brian gall
4155 hopyard road
pleasanton, CA 94588
9253296547
MDR Report Key9500026
MDR Text Key174406352
Report Number3005791775-2019-00044
Device Sequence Number1
Product Code PEW
UDI-Device Identifier00814932020001
UDI-Public00814932020001
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUROLIFT SYSTEM
Device Catalogue NumberAN00155
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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