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

Model Number	M18
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
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 reports "she has been using this product since her indiana pouch surgery in (b)(6) 2020 after suffering with interstitial cystitis for 35 yrs.She caths her stoma every 4 hr hours around the clock and flushes her neobladder 2-3 times a day with sterile water through a catheter tip syringe." she reports "finding many catheters with "rough eyelets" she estimates "about 1/4 of catheters" in her past 3 month shipment nearly used up of 600 catheters, she found to have "roughness on the eyelets." she said she always lubricates her catheter and then inserts it carefully and often has to "move it in and out" through stoma to get all residual urine out but she could feel these rough eyelets as she did this.Upon removal, despite wearing gloves, she could even feel these rough eyelets through her gloves as she checked these after feeling that.She said the soreness would last a day and go away without intervention.She also always keeps gauze covering her stoma and would also noticed blood spotting on the gauze as well after using these with catheters that had rough eyelets.She said even the following time she would cath, she would notice some blood in her residual urine that would also resolve without intervention.She said she just had her usual 6 month check up with her pcp and she relayed this occurrence to them and they checked a ua but it was found to be normal/ no uti." she was advised not to use defective catheters.This emdr covers the unknown number of catheters associated with the defect.
Additional Manufacturer Narrative
Investigation findings: retention samples (13 pieces): no defects found under magnification or by tactile inspection.Returned defective products (9 pieces): no abnormalities (e.G.Burrs or sharp edges) identified upon examination.All equipment was functioning correctly.Routine and first-article inspections were properly conducted.Cleaning and inspection logs met required standards.Production staff were trained, and procedures followed internal guidelines.Conclusion: no abnormalities found in production processes, in-process or final inspections and in retention or returned samples.However, due to the patient¿s unique catheterization method, potential contributors such as stoma scarring, improper angle, or force during insertion cannot be ruled out.Root cause & actions: root cause undetermined due to the complexity of the patient's medical condition and catheter usage.As such, no corrective or preventive actions are planned at this stage.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.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; 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: 22061732
• Report Number: 1049092-2025-00152
• Device Sequence Number: 8469386
• Product Code: EZD
• UDI-Device Identifier: 00815947020055
• UDI-Public: 00815947020055
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: M18
• Device Lot Number: 23B21401
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 01/01/2024
• 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: Female