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

Model Number	ULTRA M16
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1: (b)(6).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 reports the eyelets aren't polished, they feel "sharp." causes him discomfort in his urethra.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18622205
• Report Number: 1049092-2024-00012
• Device Sequence Number: 7668110
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• 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): 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/28/2026
• Device Model Number: ULTRA M16
• Device Lot Number: 23B05101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• 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