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

Model Number	ULTRA M14C
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
A2: age: 42, sex: male.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.Fda registration number.Reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
Consumer reports having "2 separate utis with use of the ultram14c during the beginning of this year (b)(6) 2023, unknown qty, unknown mu, unknown lots." he states earlier this year he was sent the ultram14c instead as he had an issue with qualifying for his closed system kits and he got 2 utis right after starting to use them.He then qualified back again for the closed systems but just got more ultram14c now as he was told by his supplier his closed systems are "backordered." he is using them now and has no uti symptoms but worried he will get more utis without his closed systems.When he first used these he said he got a uti in (b)(6) 2023 and then another in (b)(6) 2023 with total resolve of symptoms in between these utis for about a month.He said his uti symptoms are he starts to "feel sick, gets frequency voiding small amts frequently." he got his urine tested each time and antibiotic treatments each time." he said "he has no idea why he gets more utis while using the cure ultra as he and his wife who cath him other than the closed systems are better for uti prevention and he "just doesn't like them".Even with use of the catheter they are careful with hygiene and wear gloves as well as cleanse meatus with iodine.He drinks plenty of fluids and does not suffer constipation as he gets plenty of fiber/ and does a bowel program." this emdr is to cover the uti reported in march 2023.A separate emdr covers the uti reported in jan/feb 2023.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• 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: 17984487
• Report Number: 1049092-2023-00290
• Device Sequence Number: 7287917
• Product Code: EZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• 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): 10/19/2023

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 M14C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/23/2023
• 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: Unknown