MAUDE Adverse Event Report: CONVATEC INC 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
Event or Problem Description
End user reports "discomfort with each use due to thicker lubrication which could have possibly attributed to diagnosed uti this month while using this the last month's time - he is on his 2nd mu box he said." he said he "caths 3 x a day for the last couple years from retention from bladder enlargement/ muscle dysfunction.He was always used to using the bard magic 3 go.He said he just started using the ultram14 and said they feel more uncomfortable feeling like they sometimes "snag" and feel harder to push through the thicker lubricant makes them feel larger/harder for to him to insert despite him using always the 14fr size in his usual catheter.He said it is slower process and it takes him longer time to place and overall more uncomfortable but states they are usable.He said he never had this difficulty with the bard magic 3 gos.He does not think the ultram14 is defected in any way, just not his preference.He is not sure this discomfort with use could have lead to a recent uti but it could have.He said earlier this month while he was using the ultram14 he started feeling pain in his kidney and so he went to his primary care md who checked his urine with ua/ urine culture and it was positive for e.Coli.He was given a 10 day course of bactrim which helped a bit but still has slight soreness even after finishing course." end user was advised to reach out to his urologist.He said he hasn't had a uti in about a year and usually gets 1 x a year about.He said this is overall less than the utis he used to get more frequently prior to performing cic a few years ago.He does not was his hands prior to cathing but instead uses a hydrogen peroxide spray on his hands and then a bzk wipe on his hands.He uses the no touch sleeve to insert catheter to ensure it is not contaminated.He also then cleanses his meatus with another bzk wipe.He was advised on hand washing with soap and water for at least 20 seconds as to further prevent utis.This emdr is to address the known lot.
Additional Manufacturer Narrative
A2; age: 84, sex: male.D2: common device name: catheter, urological.E.1: complainant street address: 19th floor w city center complainant city: bonifacio global city, taguig city, philippines 1630 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).

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 17133891
• Report Number: 1049092-2023-00175
• Device Sequence Number: 6448645
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• 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): 06/12/2023

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
• Device Lot Number: 22B13702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: Unknown