MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 16FR 10ML 100%SILI DB TRA

Catalog Number	DYND160716H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end-user experienced irritation to the head of the penis.The initial reporter indicated that the end-user was at a regularly schedule urologist appointment when this irritation was noticed.The foley catheter was reportedly removed and a new foley catheter was required to be inserted with no further incident.No serious injury occurred.No follow-up care or further medical intervention reported.No sample was returned to the manufacturer for evaluation.Due to the need for foley catheter re-insertion, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the end-user experienced irritation and a new foley catheter was required to be inserted.

• Common Device Name: 1LYR 16FR 10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7453917
• Report Number: 1417592-2018-00031
• Device Sequence Number: 959660
• Product Code: OHR
• UDI-Device Identifier: 10884389235133
• UDI-Public: 10884389235133
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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?: No
• Operator of Device: Other
• Device Catalogue Number: DYND160716H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/24/2018
• 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: Required Intervention
• Patient Age: 89 YR