MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: ultram14 16in straight tip.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: (b)(4); manufacturing site: (b)(4).
Event or Problem Description
Consumer stated 'shortly after starting in (b)(6) 2022 these catheters he did develop a uti he was seen in er for.He said he cannot be sure if it was this catheter that caused it or sometimes else like him accidently touching it with hands that may have been unclean while cathing.He said the md at the er "attributed it to the friction to his urethra from this catheter" he said his urine was checked in er and it was positive for bacteria and he was given oral antibiotics and felt better'.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 16682795
• Report Number: 1049092-2023-00045
• Device Sequence Number: 17965189
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• PMA/510(K) Number: K080881
• 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): 03/17/2023

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: ULTRA M14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/05/2023
• 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