MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT SYSTEM

Model Number UROLIFT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/27/2022

Event Type  Injury  

Event Description

On 27 september 2022, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on an unspecified date.The physician reported that after the procedure the patient experienced a large pelvic hematoma which required admission to the hospital for several days and blood transfusion.The patient reported pelvic pressure and had a firm fibrinous consistency in his lower abdomen, but no infection was reported.The hematoma resolved without intervention.It was reported that the patient did very well after the resolution of the hematoma.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 15677809
• MDR Text Key: 302469355
• Report Number: 3015181082-2022-00038
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: IPN918876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male