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

Model Number	ULTRA16
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 the catheter is very hard to remove from the plastic.She says that it is hard to open the perforated plastic blister pack and sometimes both sides of the catheter plastic blister pack are perforated.She says that she has had to cut the other side of the blister pack.She mentioned that she had to do this because the catheter was hard to remove from the blister pack.She says she will be sending pictures.She also says that because the perforated side of the plastic is hard to open, the plastic blister pack rips and leaves pieces of plastic on the catheter funnel.She then has to discard these.She says that this is costly.No harm reported.
Additional Manufacturer Narrative
Device 8 of 10 e.1: complainant street address: complainant city: (b)(6) patient country: canada.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.

• Brand Name: CURE ULTRA CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• 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 ; 3365424679
• MDR Report Key: 23389059
• Report Number: 1049092-2025-00245
• Device Sequence Number: 15997306
• Product Code: KOD
• UDI-Device Identifier: 00815947020451
• UDI-Public: 00815947020451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: ULTRA16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/27/2025
• 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: Female