MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,FOLEY,100% SILICONE,8FR,5ML,LF

Catalog Number	DYND11553
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100% SILICONE,8FR,5ML,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50588579
• Report Number: 1417592-2026-31503
• Device Sequence Number: 9432698
• Product Code: EZL
• UDI-Device Identifier: 10080196848836
• UDI-Public: 10080196848836
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K082815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND11553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 64 LB