MAUDE Adverse Event Report: CONVATEC INC Cure Ultra Male Catheter

Model Number	510816
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports "he has been having back to back utis in the last 6-8 weeks while he has been using the ultram16 catheter.He reports unknown number of catheters, unknown number of market units with unknown lot numbers of the same catheter over the last 6-8 weeks.Consumer said he has been cathing for last 2 years as his bladder does not empty.He said only lately he has been getting back to back uti's and his urine turns real milky and cloudy.He said he has had 5 utis in the last 6-8 weeks.He said he goes to the md and they run urine testing and it is positive for uti.He said he was told by his md he wasn't cleaning his meatus well enough prior to catheter insertion.He was told to purchase betadine swabs to wipe his meatus with prior to cathing which he has been using ever since this was suggested.He said this has been helping a lot as his uti has not returned since he implemented this.He said before he would just use alcohol on his meatus prior to cathing and he said it never bothered his skin.He also did say he does wash his hands prior to cathing as well as uses an hand sanitizer on his hands as well.He does not ever use the no touch sleeve which he said he never knew what that was for." end user was provided guidance on use of the no touch sleeve in order to prevent utis.This emdr covers the unknown number of catheters and market units associated with the uti.
Additional Manufacturer Narrative
Brand name: ultra m16.Common device name: cure ultra® ready-to-use catheter for men.Procode: kod.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: Cure Ultra Male Catheter
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15633088
• Report Number: 1049092-2022-00384
• Device Sequence Number: 18127921
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• Combination Product (Y/N): N
• 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): 10/13/2022

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: 510816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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