MAUDE Adverse Event Report: Well Lead Medical Co., Ltd. Ureteral Access Sheath, 11-13 Fr x 36cm

Model Number	XUSM0045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Tba.

• Brand Name: Ureteral Access Sheath, 11-13 Fr x 36cm
• Common Device Name: Ureteral Access Sheath, 11-13 Fr x 36cm
• Manufacturer (Section D): Well Lead Medical Co., Ltd.; c-4 jinhu; industrial estate hualong; panyu, guangzhou CN 51 1434; CH CN 511434
• MDR Report Key: 50810339
• Report Number: 2020550-2026-02105
• Device Sequence Number: 18785640
• Product Code: FED
• UDI-Device Identifier: 16944932747910
• UDI-Public: 16944932747910
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: XUSM0045
• Device Catalogue Number: XUSM0045
• Device Lot Number: 2605133401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 109 LB