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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 01/10/2020
Event Type  malfunction  
Event Description
On 10 jan 2020, neotract was informed of successful prostatic urethral lift (pul) procedure during which a delivery device did not deployed properly, there was no patient injury or harm reported, and the device was returned for investigation.On 04 feb 2020, neotract's device analysis confirmed that a 1 -2mm needle tip was missing from the returned device.Neotract had notified the physician of the missing needle tip.
 
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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 Key9793193
MDR Text Key194203711
Report Number3005791775-2020-00014
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 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number73L1900620/2776920
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2020
Initial Date FDA Received03/05/2020
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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