MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS; CATHETER, URETHRAL

Model Number	510813
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "the eyelets he noted what looked to be plastic "spurs" coming off the eyelets.He further described it as "like someone took toe nail clippers and cut the plastic on it." he said this defect was on about 30 catheters from unknown lot # and unknown mu.He has since thrown away the catheters as this occurred 3-5 weeks ago.He said he had only used on himself about 3 or 4 of them before he noticed the problem on a total of about 30 catheters.He noticed it because the catheter hurt going into his urethra and he noted a "little bit of blood" when pulling the catheter out and that dripped from his urethra each of these 3-4 times.He held pressure to his meatus with toilet paper to blot it for 2-3 min and then it stopped.After this occurred, he inspected the catheters by wiping them off with toilet paper and even the toilet paper would get caught on the plastic parts he described as plastic "spurs" near the eyelets.He even could tell they had this defect when he took out his magnifying lens.He did not seek medical attention for the bleeding that occurred.".
Additional Manufacturer Narrative
Device 26 of 30.Common device name: catheter uretheral.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 (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
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.

• Brand Name: L3C0600 - CURE PRODUCTS
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14222084
• Report Number: 1049092-2022-00243
• Device Sequence Number: 5358899
• Product Code: GBM
• UDI-Device Identifier: 10815947021103
• UDI-Public: 00815947021106
• Combination Product (Y/N): N
• PMA/510(K) Number: K072539
• 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): 03/29/2022

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: 510813
• 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): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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: Male