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

Model Number	M16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.1: complainant street address: (b)(6).This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Based on the available information, this event is deemed to be a serious injury.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
It was reported "consumer is a sci patient in a wheelchair since 1996 and has cathed for many years.Has a very spastic bladder and caths every 4-6 hrs for incontinence.End user states he was supposed to get the m14c catheter as this has been the catheter he has used for years, however "he was sent in error the m16 straight tip and this one caused him the concerns.He does not have issues of bleeding with the m14c and this has been a catheter he has used for years, his preferred catheter.He said he was traveling overseas for a christmas holiday so when he packed his catheters, he did not at all notice that some he was recently sent were the m16 as they were all in the same cure boxes he has been used to.He said he only had a few boxes of m14c packed along with him but then when he ran out of those overseas, he had to use the m16.He had only noticed these were a different fr size and tip type when he was overseas.He said he would apply extra ky jelly to them but still harder to insert and get through sphincter.He said he had off an on bleeding with use of them, very light bleeding with use as this was not his correct fr size nor tip type.He said he cannot be sure what caused it but this irritation with use of this product could have contributed to a uti he recently was diagnosed with and just finished a round of antibiotics for, feeling much better now." end user states "he thinks traveling overseas also could have contributed to his uti as it was difficult to find wheelchair friendly bathrooms and then also typically when he has to void, he has urgency due to his spastic bladder and does not typically cleanse meatus prior to cic stating he doesn't often get utis." end user was reminded to always check catheters to ensure they are the correct type as prescribed by his md.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 21228983
• Report Number: 1049092-2025-00046
• Device Sequence Number: 12847391
• Product Code: EZD
• UDI-Device Identifier: 00815947020048
• UDI-Public: 00815947020048
• 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
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/24/2025
• 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