MAUDE Adverse Event Report: CONVATEC Cure Ultra Male Catheter

Model Number	510810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: catheter, straight.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number : reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
Consumer states he got a uti while using an expired box of the ultram10 catheters - 1 mu, qty 30 catheters, lot # 190616-3.He said he didn't really pay attention when he grabbed this box of catheters from his storage and he said he used the whole box before he realized they were expired in 2021 and resulted in him getting uti as he did use the box of expired catheters prior to his uti.He did note the lubricant was yellow-ish looking.I explained to him the importance of not using expired catheters, he is aware he has to pay more attention to the dates from now on.He caths 3-4 times a day for retention from spina bifida.He said these catheters typically work well for him overall when not expired.He said he realized he had a uti as he was having burning, lower back pain and frequency.He went to get his urine tested and he did have an antibiotic prescribed by his doctor and he is now on day 3 of a 10 day course of antibiotics, name unknown.He still has some of the frequency but getting better on antibiotic course.

• Brand Name: Cure Ultra Male Catheter
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15499739
• Report Number: 1049092-2022-00368
• Device Sequence Number: 12218569
• Product Code: KOD
• UDI-Device Identifier: 00815947021045
• UDI-Public: 00815947021045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: Lay User/Patient
• Device Model Number: 510810
• Device Lot Number: 190616-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male