MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510816
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: cure ultra® ready-to-use catheter for men.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 (b)(4).
Event or Problem Description
End user reports "at the beginning of the month he had a uti which he said "he doesn't get many of." he also thinks this occurred because of his anatomy as recently also his channel has been feeling tighter to pass his normal 16 fr size catheter through in general which started prior to his uti.Some resistance also noted and some discomfort noted when cathing as well in general with 16fr.Denies pain.He thinks he may need a smaller catheter.He is not sure if this was further aggravated because not enough lubrication on some catheters he had started using at that time.His uti symptoms were burning and pressure.He had to do a urine test and an get antibiotics course in order for symptoms to go away." end user was advised not to use catheters without sufficient lubrication.

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 14950047
• Report Number: 1049092-2022-00309
• Device Sequence Number: 6214646
• Product Code: OHR
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• 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
• Report Date (Section B): 06/28/2022

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 Expiration Date: 09/28/2024
• Device Model Number: 510816
• Device Lot Number: 211012-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• 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 Sex: Male