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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
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NEOTRACT, INC. UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM Back to Search Results
Catalog Number UL400-4
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Electrolyte Imbalance (2196); Hematuria (2558); Dysuria (2684); Hyponatremia (4494)
Event Date 10/08/2021
Event Type  Injury  
Event Description
After a urolift procedure was performed on an outpatient basis, i experienced serious bleeding and inability to urinate 3 days post procedure.I was hospitalized with diagnoses of hematuria, acute hyponatremia and hypokalemia.Discharged from the hospital on (b)(6) 2021 with a foley catheter with instructions to report to urologist on monday for foley removal.Foley successfully removed on (b)(6) 2021.Significant bleeding (blood in urine) occurred on (b)(6) 2021 along with significant pain on urination and difficulty in urination.Went to er and was diagnosed with urinary retention, infection or inflammation of bladder urinary tract infection and discharged with ciprofloxacin hcl 500 mg (1 tablet by mouth 2x daily).Fda safety report id# (b)(4).
 
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Brand Name
UROLIFT
Type of Device
IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
MDR Report Key12665049
MDR Text Key277771104
Report NumberMW5104768
Device Sequence Number1
Product Code PEW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUL400-4
Device Lot Number73F2100537
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age64 YR
Patient Weight75
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