URINAL DYND80235S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-14 for URINAL DYND80235S manufactured by Medline Industries, Inc..

Event Text Entries

[4190127] The patient suffered a cut to his penis from a sharp edge on the urinal.
Patient Sequence No: 1, Text Type: D, B5

[11490123] It was reported that while using the urinal, a male patient suffered a cut to his penis from a sharp edge on the rim. The cut was repaired with surgical adhesive without further incident. The size and extent of the laceration was not reported. The actual sample was not retained for evaluation and the lot number of the device is not known.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1417592-2014-00002
• MDR Report Key: 3600580
• Report Source: 05,06
• Date Received: 2014-01-14
• Date of Report: 2014-01-09
• Date of Event: 2013-12-11
• Date Mfgr Received: 2013-12-11
• Date Added to Maude: 2014-01-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 3
• Manufacturer Contact: JULIE FINLEY
• Manufacturer Street: ONE MEDLINE PLACE
• Manufacturer City: MUNDELEIN IL 60060
• Manufacturer Country: US
• Manufacturer Postal: 60060
• Manufacturer Phone: 8476434709
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: URINAL
• Product Code: FNP
• Date Received: 2014-01-14
• Catalog Number: DYND80235S
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: MUNDELEIN IL US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-14