MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,FOLEY,COUDE,LATEX,16FR,10ML

Catalog Number	DYND11216
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,16FR,10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska
• MDR Report Key: 50598541
• Report Number: 1417592-2026-32220
• Device Sequence Number: 18667973
• Product Code: EZL
• UDI-Device Identifier: 40080196726760
• UDI-Public: 40080196726760
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: DYND11216
• Device Lot Number: 59222010143
• 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): Yes
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 119 LB