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

Model Number	510858
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer states the catheters m16c feel like some of them have a "bur" on the end of them that scratch him at the very tip when they enter his bladder and sometimes cause him to have minor bleeding after.He has used these catheters since he started cathing in (b)(6) 2017 and feels the problem is getting worse.He thinks it is a quality control issue.At times, he has small quantities of blood as well that can be visible as he retracted the catheter and sometimes he notes it when he cleans his meatus or even a short time after.He said it is not a lot of blood and not noted in his urine.He is not on blood thinners.He notes no abnormality with the catheter itself visibly prior to cathing.He said he sees no abnormality with the eyelets.He does say that he sometimes puts the coude tip in his meatus to the right/ left or down, not always upwards.I relayed to him the proper way to place a coude tip is upwards and he said he will try that.He has not seen his urologist in a long time over a year stating they just want to give him medications and he can teach his doctor about his condition.He said he has an appointment next week with his pcp.He started cathing because of retention issues and a intestinal fistula caused by his diverticulosis also caused a connecting fistula in his bladder.He had repairs with mesh in 2017.He caths 3-4 x a day.
Additional Manufacturer Narrative
Device 15 of 31.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.(b)(4).

• Brand Name: L3C0600 - CURE PRODUCTS
• Common Device Name: CATHETER URETHRAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14243229
• Report Number: 1049092-2022-00261
• Device Sequence Number: 11941768
• Product Code: OHR
• UDI-Device Identifier: 00815947020093
• UDI-Public: 00815947020093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K132500
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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 Expiration Date: 06/28/2026
• Device Model Number: 510858
• Device Lot Number: 210731-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• 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 Age: 83
• Patient Sex: Male