MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 16, 2024, neotract was made aware by a physician, via a docmatter discussion thread titled ¿nickel allergy developed post urolift.Best way to remove all implants?¿, that ¿physician have a 50 year old male who developed a generalized mild rash after urolift.No other new meds or conditions that were suggestive of a cause, therefore, the physician urged him to go get allergy tested.Patient come back allergic to most metals including nickel.Patient has never had this issue before and was well informed, as patient is actually a clinical trial patient.Patient would like all the clips removed.What's the best way of removing all the clips (including the capsular tab where the nickel is located) and the least invasive / least traumatic manner?¿ additional information received on july 30, 2024, indicated that the patient participated in the urolift impact study and underwent a pul procedure using the ul2 device.The rash was described as intermittent, and the patient took benadryl to alleviate symptoms.Further clarification received on the same date (july 30, 2024) described the patient's symptoms as more of an itchy sensation rather than a rash, beginning two weeks post-procedure.The itching initially affected the scrotum and later spread to the anus, inner and outer thighs, top of the foot, and toes.The symptoms persisted throughout the day, with a marked increase in severity at night.The patient also reported scarring from scratching on the top of the foot and ankle.The urolift procedure was performed on (b)(6) 2024, using devices from lot numbers 73e2300723x6 and 73a2300411x1.On september 17, 2024, the physician provided further updates via a docmatter post, stating that the urolift clips were removed via a turp procedure using graspers.The patient's itching and rash had significantly improved and may have completely resolved.

• 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 ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316, rancho el descanso; tecate ; MX
• Manufacturer Contact: laura gonzalez serrano ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 20419245
• Report Number: 3015181082-2024-00026
• Device Sequence Number: 20943615
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/10/2024

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 Expiration Date: 05/22/2024
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN924184
• Device Lot Number: 73E2300723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male