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

Model Number	HM14
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
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
Consumer states "he started cathing 4 or 5 years ago after back surgery for degenerative discs and it affected his bladder ability to empty.He has arthritis, recent recurrent knee infections on his knee replacement.No history of bph, no history of kidney stones.Has said this has been his preferred catheter.Just this year he said for unknown reason or cause (not blaming the catheters) he has been getting recurrent utis, he said "4 or 5" of them." he said "for this last flare up of uti symptoms last week he said he was on doxycyline and an antibiotic that starts with a "c" for a recent knee infection." this emdr covers the unknown number of catheters associated with the utis.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Per the investigation, retained samples of the complaint lot were reviewed.Pouches are intact, tips are closed smoothly without burr or hole over-melt.Eyes are smooth without burr, no sharp edge or material shaving and coating looks normal.Conclusion ¿ record shows the product under lot 23b20901 keep sterility.The product has no quality issue.Products are in sterilized condition and will not cause uti to the user.Should additional information become available, a follow-up report will be submitted.Fda registration number : reporting site: 1049092, manufacturing site: 3005471919.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 20406774
• Report Number: 1049092-2024-00120
• Device Sequence Number: 6479791
• Product Code: EZD
• UDI-Device Identifier: 00815947020314
• UDI-Public: 00815947020314
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: HM14
• Device Lot Number: 23B20901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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