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

Model Number	ULTRA12
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
A2: sex, female; age, 65.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
End user reports the catheters "they feel too flexible like they "reduced the amount/ quality of the plastic" they are using on them making them too bendable now.She was always able to place them in urethra by feel just fine without a mirror easily.She said now they are just bending, difficult to place and often slide into vagina.Using a mirror helps but without it, she finds she can go through qty"10" for each time she caths until 1 finally goes in and this has never been the case before.She uses so many as she doesn't want to use a catheter that has been contaminated in any way having not gone straight into urethra.She said all the catheters in her last 2 orders have been like this and she will run out before her next order since she has to use so many to get one to go in since they bend so easily.They are stored in a 74 degree room.She was "diagnosed with a uti" in (b)(6) from her primary.She thinks all the "poking around" because of this change she has noted in the plastic and with the catheters bending possibly this could have caused this.She had no uti symptoms at the time.It was an annual physical and they did a routine urine test.Her md called her with the results of the urine culture and she said she was told it showed a high count of e.Coli bacteria, was a uti and that because of her joint replacement to err on the side of caution she was rx'd 7 day course of antibiotics.They were aware she caths.She took the antibiotics and they did not recheck the urine.She never had any uti symptoms." she said she has never had a uti before or ever any uti symptoms.She said she is very fastidious about cleanliness when cathing as she is a retired microbiologist.

• 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: 17606786
• Report Number: 1049092-2023-00243
• Device Sequence Number: 20410202
• Product Code: KOD
• UDI-Device Identifier: 00815947020437
• UDI-Public: 00815947020437
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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 Expiration Date: 09/28/2025
• Device Model Number: ULTRA12
• Device Lot Number: 22B26303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• 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