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

Model Number	ULTRA M16
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.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
End user states "he saw the cure catalogue that was sent with them and on the first inside page it has a picture of the eyelets being polished and he said the ones he received feel sharp if he runs his finger down them they do not feel like those look in the picture.He said he feels like the catheters eyelets are no longer polished anymore as he has previously used this product for years.He said especially the first half inch in his urethra it feels sharp like eyelets are "scarping him" as he advances it.They don't look as polished, hard to see but felt more.He denies any bleeding with use but it is very uncomfortable he said.".
Additional Manufacturer Narrative
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
Per additional information received "he said he really cannot be sure if the eyelets changed in any way as he never paid attention to them before or if it was ¿all in his mind.¿ he thought the eyelets had looked and felt more polished in the past, but had never checked them before he started to feel the problems he had reported to me.He thinks maybe they may have changed but ¿cannot prove it.¿ he overall said the problem was him and his anatomy ¿ urethral stricture that had formed as he needed this dilation procedure that the urologist had to perform on him for cathing to feel comfortable again for him with this same product.".

• 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 27409 ; 3365424679
• MDR Report Key: 18629104
• Report Number: 1049092-2024-00014
• Device Sequence Number: 7834907
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 02/01/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/28/2026
• Device Model Number: ULTRA M16
• Device Lot Number: 23B05102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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