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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 UL400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Failure (2041)
Event Date 08/11/2019
Event Type  Injury  
Event Description
On 24 april 2020, neotract was notified of an adverse event from the real world retrospective study: on (b)(6) 2019, a patient underwent a successful prostatic urethral lift (pul) procedure.Post procedure, it was reported that the patient experienced urinary retention for nine days requiring catheter placement, and he was hospitalized for several days due to renal failure.No additional information was available.
 
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Brand Name
NEOTRACT UROLIFT SYSTEM UL400
Type of Device
UROLIFT SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
4155 hopyard rd
pleasanton CA 94588
Manufacturer (Section G)
NEOTRACT, INC.
4155 hopyard rd.
pleasanton CA 94588
Manufacturer Contact
brian gall
4155 hopyard rd.
pleasanton, CA 94588
9253296547
MDR Report Key10081176
MDR Text Key192141134
Report Number3005791775-2020-00025
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 study
Reporter Occupation Physician
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUL400
Device Catalogue NumberAN00094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2020
Initial Date FDA Received05/21/2020
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;
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