MAUDE Adverse Event Report: CONVATEC L3C0600 - CURE PRODUCTS

Model Number 510828

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

End user reports unknown number of catheters, unknown number of market units, stating maybe "5 or more" with unknown lot numbers of the same catheter over the last month shipment, lot/s unknown.She states the caps were difficult to remove and of all these hard to open catheters they seemed like the lubrication was more dried out at the tip, "not as full" as they used to be with lubricant.She has been using these catheters for a long time.She said the caps that were difficult to remove was her "first clue" these catheters were defected.She said she had to have her husband open them all for her before he left on a work trip or else she was going to "get a tool from his toolbox to open them" as she could not open them which normally she can open them herself.No other abnormalities on the catheters themselves.She mentioned she is recovering from a uti that was discovered last week.She said you "can't blame the catheters." she does not feel the defected catheters were the cause of her utis.She has cath'd for 7 years and 5 x during the day and 2 x at night for retention.She said she wipes genital area prior to placement with antibacterial wipe, she is cautious to keep the sterility of catheter prior to placement but it has been difficult for her to find her urethral opening and sometimes she will "poke around" before she gets it in.She states she had a series of utis 4-5 years ago, she had a break from utis for 2-3 years and now this was her first one recently.She also has history of kidney stones a long time ago which she passed she said.She said recently around last week she was certain she had a uti, she felt overall very sick, fatigued and had frequency/urgency denies malodorous urine, denied blood in urine or cloudy urine, denies fever.She said she called her doctor and they had her do a urine test (ua and urine culture) at the lab which was positive for uti.She was started on macrobid and switched to cefdinir which she finished.Over the weekend she did a repeat urine test which showed she cleared the infection however she said she still feels sick overall.She has a doctor appt tomorrow.

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.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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).

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 14787821
• MDR Text Key: 295060963
• Report Number: 1049092-2022-00301
• Device Sequence Number: 1
• Product Code: EZD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 00815947020390
• Combination Product (y/n): N
• PMA/PMN Number: K072539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 510828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female