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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 07/12/2021
Type of Reportable Event Serious Injury
Event or Problem Description
On 12 july 2021, neotract was made aware of a patient that received a successful prostatic urethral lift (pul).In post-procedure recovery, it was discovered that the patient had developed a hematoma and he was admitted.The physician surgically repaired the bleeding artery and the patient required blood transfusion.The patient was released from the hospital after five days and was reported to be stable and improving.
 
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Brand Name
NEOTRACT UROLIFT SYSTEM
Common Device Name
UROLIFT SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
4155 hopyard road
pleasanton CA 94588
MDR Report Key12305114
Report Number3015181082-2021-00023
Device Sequence Number17270104
Product Code PEW
UDI-Device Identifier00814932020001
UDI-Public00814932020001
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K193269
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberUROLIFT SYSTEM
Device Catalogue NumberAN00155
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date08/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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