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

Model Number	HM16
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 reports for 7 yrs he has "constantly gotten utis".He does not know exactly why he has gotten so many despite following up with his urologist.He could not provide how many diagnosed utis but said a lot, could not provide many details saying it is all in his medical records.He has needed multiple rounds of antibiotics prescribed by his md and multiple ua and urine cultures over the years.He is a long-time user of our cure hm16 when he has been diagnosed with these utis over the years.He said he is aware they are manufactured in china and says that should be labeled clearer on the box.He said he has been to china over 40 times for work trips and is concerned about the sterility of such an item coming from that country based on his experiences.He said he has suspected concerns about the sterility of the water used in the packets.No outward signs of any abnormality with the product itself it is just a thought he had.He said he is very mindful about hygiene washes his hands, at homes uses alcohol prep pads to cleanse meatus, does not contaminate the catheter and uses no touch sleeve.When he is out of his home in a bathroom stall, he will also use soap and water paper towels twice to cleanse meatus as well for extra cleanliness.He said his utis have "been a constant struggle", at times he said he will feel good for a week after antibiotic treatment course, but the infection will come right back.He said his main uti symptoms is notable increased fatigue and even increased bleeding as noted in case 1 he has had on and off even without utis.No additional information was provided.This emdr covers the unknown number of catheters with unknown lot numbers of the same catheter associated with the uti's.
Additional Manufacturer Narrative
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.Fda registration number: reporting site: 1049092.Manufacturing site: 3005471919.
Additional Manufacturer Narrative
Investigation: 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, sop-000741.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CURE CATHETER
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24288261
• Report Number: 1049092-2026-00047
• Device Sequence Number: 9332434
• Product Code: EZD
• UDI-Device Identifier: 00815947020321
• UDI-Public: 00815947020321
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 01/30/2026

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: HM16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/08/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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 Age: 71 YR
• Patient Sex: Male