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

Model Number	ULTRA M16
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.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).
Event or Problem Description
It was reported a consumer used quantity of 5 from a sample pack of 10 sent to him.States they feel like upon removal they felt "glued to his urethra." he is following ifus to prepare and uses this gc glide catheter right away after preparation by activating water sachet prior to inserting to drain his bladder.He said it takes him about 1 minute 15 seconds for him to drain bladder and remove but when he goes to remove the catheter it feels like it is somewhat "glued to urethra" and it is "unpleasant" to remove it from entire length of urethra.

• 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: 16400642
• Report Number: 1049092-2023-00023
• Device Sequence Number: 20235264
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: ULTRA M16
• Device Lot Number: 2F01247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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: Male