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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM
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HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM Back to Search Results
Model Number UROLIFT 2 SYSTEM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 04/17/2024
Type of Reportable Event Serious Injury
Event or Problem Description
On 22 april 2024, neo tract was informed of a patient who underwent a pul procedure on (b)(6) 2024.The procedure was uneventful, with two implants placed.Post-procedure, the patient presented to the emergency department with irritation and was believed to have a ¿nick in the bladder or a perforated bladder¿.No additional information was received.
 
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Brand Name
NEOTRACT UROLIFT 2 SYSTEM
Common Device Name
UROLIFT 2 SYSTEM
Manufacturer (Section D)
HUDSON RESPIRATORY CARE TECATE
prolongacion mision eusebio ki
no. 1316,rancho el descanso
tecate
Manufacturer (Section G)
HUDSON RESPIRATORY CARE TECATE
prolongacion mision eusebio ki
no. 1316,rancho el descanso
tecate
MX  
Manufacturer Contact
nikitha penumetsa
4155 hopyard road
pleasanton, CA 94588
9195448000
MDR Report Key19766217
Report Number3015181082-2024-00018
Device Sequence Number8624750
Product Code PEW
UDI-Device Identifier10814932020343
UDI-Public10814932020343
Combination Product (Y/N)N
Initial Reporter StateCA
PMA/510(K) Number
K193269
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/17/2024
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 2 SYSTEM
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/22/2024
Initial Report FDA Received Date07/17/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexMale
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