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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 UROLIFT SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
Event Type  malfunction  
Event Description
On 12 oct 2020, neotract received a report that a physician experienced a delivery device that did not properly deploy during the prostatic urethal lift (pul) procedure.The procedure was successfully completed using additional devices.On 04 nov 2020, neotract's device analysis indicated that the returned device was missing approximately 1.5mm of the needle tip.Neotract notified the physician of the investigation results.On 19 nov 2020, the physician stated that the patient reported no issues and the physician will perform a follow-up examination at a later time.
 
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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 Key10938040
MDR Text Key219368905
Report Number3005791775-2020-00050
Device Sequence Number1
Product Code PEW
UDI-Device Identifier00814932020001
UDI-Public00814932020001
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K193269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUROLIFT SYSTEM
Device Catalogue NumberAN00156
Device Lot NumberP44500
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/26/2020
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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