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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 Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020, neotract was made aware of a physician that experienced multiple delivery devices that did not properly deploy during the prostatic urethral lift (pul) procedure.The procedure was successfully completed using additional devices.On 23 november 2020, neotract's device analysis indicated that one of the returned devices was missing approximately 1mm of the needle tip.Neotract notified the physician of the investigation results.On (b)(6) 2020, the physician stated that the patient is doing well and there are no planned follow-ups at this 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
brian gall
4155 hopyard road
pleasanton, CA 94588
9253296547
MDR Report Key11029292
MDR Text Key229609137
Report Number3005791775-2020-00053
Device Sequence Number1
Product Code PEW
UDI-Device Identifier00814932020001
UDI-Public00814932020001
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193269
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 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUROLIFT SYSTEM
Device Catalogue NumberAN00155
Device Lot NumberP44657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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