MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M14
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
Event or Problem Description
End user states he has used this catheter since (b)(6) 2022.He caths 2 x a day for retention and prevention of hydronephrosis.He states "many years ago he had systemic vascularitis and was on a medicine called cytotoxin which affected his bladder lining and he developed bladder cancer." he mentions that "since he has started cathing in his life since (b)(6) 2022 he has gotten "4 or 5 utis".He said it is due to resistant bacteria he has in his bladder.He specifically said he does not think it is the fault of this catheter at all.He said lately he has been doing "pretty good" recently and his last uti was a few weeks ago.His symptoms are typically burning, urgency and leakage.Most of the time he goes in for a ua and urine culture and gets prescribed an antibiotic.His last uti he said they did not have him do that and just prescribed him medication on the phone as it was a weekend call.He mentioned he has had the antibiotic bactrim twice and then they had to switch antibiotics after one of his past urine cultures and he didn't have problems after that.He could not remember names of the other antibiotics.He said he is careful in wiping down his hands and outer packaging of his catheter/ iodine prep pad with disinfectant wipes and then washes his hands with antibacterial wipes, wipes on a clean hand towel and then uses the iodine wipe on his meatus and uses the no touch sleeve never contaminating the catheter.He is working with his md regarding these utis but lately has been doing well.Again, he said he does not think his utis are caused by the ultram14 catheter.".
Additional Manufacturer Narrative
Age 70 years.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 PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 16664178
• Report Number: 1049092-2023-00042
• Device Sequence Number: 17625685
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K080881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: ULTRA M14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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