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

Model Number	HM14
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reported using 15 of 30 catheters that 'all feel like they are sticking the length of his urethra upon removal'.He stated he ordered these from his supplier and reports these from this box all feel like they are sticking upon removal from his urethra.Additionally, he stated he feels this the length of his urethra upon removal and especially noted by the upper portion of catheter near the funnel.He reported this "sticking" upon removal at most creates discomfort with use upon removal.No further harm was reported.
Additional Manufacturer Narrative
Device 3 of 15.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
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.Investigation findings: coating process review: personnel were properly trained and equipment functioned normally.Coating application met specifications, and factory inspections showed no defects.Retained sample tests (13 units) confirmed coating height and hydration levels met standards.Friction tests showed proper coating reduced resistance, but uncoated sections had 50x higher friction.Water bag process review: production and inspection records were normal.No abnormalities found in packaging process.Water infiltration levels within required range.Final conclusion: no production defects identified.Possible cause: individual anatomical variations may lead to uncoated catheter sections contacting the urethra, increasing friction.Due to lack of user-provided physical samples or images, root cause remains unclear.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, sop-000741.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 3005471919.

• Brand Name: CURE PRODUCTS
• 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 ; 3367062840
• MDR Report Key: 20765164
• Report Number: 1049092-2024-00137
• Device Sequence Number: 8532965
• Product Code: EZD
• UDI-Device Identifier: 00815947020314
• UDI-Public: 00815947020314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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 Model Number: HM14
• Device Lot Number: 24B00202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: Male