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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM
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NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM Back to Search Results
Model Number UL400
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020, neotract was informed of a successful prostatic urethral lift (pul) procedure during which the physician could not visualize the suture after needle deployment.No patient injury or harm was reported.On 20 feb 2020, neotract's investigation of the device indicated that 2mm of the needle tip was missing.Neotract notified the physician of the investigation results.On 11 march 2020, the physician acknowledged the missing needle piece.No additional information is available at this time despite multiple outreach attempts.
 
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Brand Name
NEOTRACT UROLIFT SYSTEM
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
kathyrene logrono
4155 hopyard road
pleasanton, CA 94588
9253296521
MDR Report Key9859631
MDR Text Key192141821
Report Number3005791775-2020-00015
Device Sequence Number1
Product Code PEW
UDI-Device Identifier00814932020049
UDI-Public00814932020049
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUL400
Device Catalogue NumberAN00136
Device Lot Number73L1900133/2765526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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