MAUDE Adverse Event Report: L3C0600 - CURE PRODUCTS

Model Number 510827

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Common device name: kod,  catheter, urological.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).

Event Description

Consumer reports t12 catheter caused a uti, unknown qty from unknown mu, unknown lot/s at this time.She states last month she wanted to try a catheter with a funnel end so urine would spray less as she was used to using the speedicath compact catheters with a "waffle end" that tended to spray when draining.She asked her supplier to send her the t12 as she remembered having good experiences with the t10 back about 2 years ago when she first learned to cath.She said overall when she got the t12 they felt more uncomfortable and discomfort would last 1-2 min after cathing.She thinks they felt more like they were scrapping her urethral sides.She said shortly after using these she got a uti and she thinks it was the catheter that caused them as they felt more "traumatic to insert" because of this discomfort when inserting she said.She said she knew she had a uti when she started having urgency, frequency and like she could not void on her own.This started a few weeks after starting use of these catheters.She then said she saw light pink blood mixed with urine when she cath'd and she knew she had a uti.She called her doctor and they had her do a urine test at the lab which she said it was positive for uti.She said the bacteria was e.Coli - she is a nurse she said.She was given 5 days of cefalin antibiotic and by the end she didn't feel better so she noted a refill on the bottle and took the other 5 days and then felt better.She said she had a repeat urine test 4-5 days ago and it was clear of uti.She said she always makes sure she washes her hands or uses hand sanitizer if water not available prior to cathing.She always makes sure catheter stays sterile prior to inserting.She uses an aloe vera wipe on her urethral opening prior to cathing, not an antibacterial wipe which she said she will discuss with her doctor.After showers in the morning she said she typically doesn't wipe urethral opening prior to cathing.She said she knows she is more prone to utis because she caths but she hasn't had a uti "in a good long spell" and that is why she thinks it was the catheters that caused this uti.She is seeing her urologist for follow up today.

• Brand Name: L3C0600 - CURE PRODUCTS
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14754261
• MDR Text Key: 295030998
• Report Number: 1049092-2022-00300
• Device Sequence Number: 1
• Product Code: EZD
• UDI-Device Identifier: 00815947020383
• UDI-Public: 00815947020383
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 510827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• 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