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

Model Number	M14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	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 ""sharpness to the outside tubing and were causing cutting sensation when inserting and removing." he further stated "he used lubricant and often uses these caths.Issues were abnormal.He did not see anything on the cath specifically to identify the issue.He is on blood thinners so he does have higher risk of bleeding, but the cath is painful to use.".
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
10pcs of retained samples from the complaint lot was reviewed.Tips are smoothly closed, no burr or distortion.Eyelets are punched smoothly, without any burr, no sharp edge.From the investigation, there is no abnormality during the manufacturing process.Considering the user process, during insertion or withdraw, the urethral mucosa may be irritated or damaged, resulting in a painful reaction.In addition, as a foreign body of non-ontological tissue, the presence of the catheter itself may also have a certain stimulating effect on the urethra, thereby causing pain.As no useful information like a returned sample, or picture or video is provided, the supplier cannot find the root cause for the complaint.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, URETHRAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 20278350
• Report Number: 1049092-2024-00113
• Device Sequence Number: 18137583
• Product Code: GBM
• UDI-Device Identifier: 00815947020086
• UDI-Public: 00815947020086
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/16/2024

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: M14C
• Device Lot Number: 22B30502
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 12/28/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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