MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510828
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
Common device name: cure twist® ¿ ready to use catheter for women.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
Consumer reports "this catheter was too short for her anatomy." she states "about 6 months ago she thought this product could have given her a uti because it was short for her anatomy and she ended up touching her hand to her urethral opening often to get it to work to drain her bladder as it was shorter to her previous catheters.She reports use of several catheters, from unknown lot numbers from multiple unknown mu about 6 months ago, she no longer has.She states "she gets utis more than a normal person" but thought the catheters were the cause 6 months ago because the infection was so hard to clear which is not normal for her while she was using these catheters.Shortly after getting these catheters, her uti symptoms began, she had frequency, urgency, pressure in bladder and dysuria and knew she had a uti.She went into immediate care and it was deemed she had a uti after urine testing and she was prescribed a course of antibiotics.That course of antibiotics didn't work she said she was switched to another one and then still her symptoms didn't clear so she had another ua and urine c&s done by her doctor and she got a new antibiotic which finally cleared the infection.She then switched to normal bard magic 3 go's and has done much better with these.She said she does not typically wipe her urethral opening prior to catheter insertion with antibacterial wipe." she was advised to do so in order to prevent uti.

• 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: 14014327
• Report Number: 1049092-2022-00096
• Device Sequence Number: 17283003
• Product Code: EZD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 00815947020390
• 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): 03/29/2022

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 Model Number: 510828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female