MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER, RETENTION TYPE, BALLOON

Model Number	DYND11760
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There have been a few accounts of medline silicone-elastomer coated latex catheters dysfunctions.Patient underwent robotic prostatectomy.Patient was discharged home with silastic foley catheter.Patient presented to emergency dept two and a half weeks post op, after catheter balloon malfunctioned and catheter "slipped out." patient required foley catheter replacement via cystoscopy in the ed.

• Brand Name: MEDLINE
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 11663607
• Report Number: 11663607
• Device Sequence Number: 3097351
• Product Code: EZL
• UDI-Device Identifier: 10080196726547
• UDI-Public: (01)10080196726547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/31/2021
• Report Date (Section F): 03/31/2021

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
• Operator of Device: No Information
• Device Model Number: DYND11760
• Device Catalogue Number: DYND11760
• Device Lot Number: (10)59220122557
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/31/2021