MAUDE Adverse Event Report: Well Lead Medical Co., Ltd McKesson Brands; CATHETER, FOLEY STRT TIP SIL COATED LTX 16FR 5CC

Catalog Number	16-SLFOL522
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer the balloon not deflating, they are having to pop the balloon inside the patient and remove it.At least 3 patients needed er assistance for removal and one of those patients required surgery.

• Brand Name: McKesson Brands
• Common Device Name: CATHETER, FOLEY STRT TIP SIL COATED LTX 16FR 5CC
• Manufacturer (Section D): Well Lead Medical Co., Ltd; 47 guomao avenue, hualong; guangzhou, guangdong 51143 4; CH 511434
• MDR Report Key: 50008330
• Report Number: 50008330
• Device Sequence Number: 14937609
• Product Code: EZL
• UDI-Device Identifier: 10612479245942
• UDI-Public: 10612479245942
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026
• Report Date (Section F): 07/23/2026

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 Catalogue Number: 16-SLFOL522
• Device Lot Number: CAOE05-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2026
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/23/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/28/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/23/2026