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

Model Number 510827

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Common device name: catheter, urological.Procode kod.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.(b)(4).

Event Description

End user reports "she has had a recent uti while using the t12 catheter - she reports unknown qty from unknown mu/s with unknown lot #s." she said she has been using 2 different kinds of catheters prior/ during her recent uti, one catheter being the t12 over the last month and another kind of catheter she doesn't know the name of.She said she "isn't sure the cause of her utis, she said she is not sure if it is the catheters.Her uti has been on/ off for the last month and as soon as she finishes a round of antibiotics her uti symptoms return.She said it started with cloudy urine, back pain and the feeling she was always in retention - urgency and stomach pains.She said she had her urine tested at the lab and had a ua/ urine culture she had different rounds of antibiotics this past month but "nothing is getting rid of it." she is not constipated.She has no history of kidney stones." end user was advised she needs to follow up with her doctor which she plans on doing soon.She said she "does not ever wipe her urethral opening prior to cathing and she said she thinks she needs to get some wipes for uti prevention.She also said she doesn't wash her hands prior to catheterization, only after." the importance of washing her hands prior to cathing for uti prevention was discussed with the end user in order to reinforce the importance of the catheter staying as sterile as possible as well.End user reports cathing 5-6 x a day for retention.

• Brand Name: CURE PRODUCTS
• Type of Device: CATHETER, STRAIGHT
• 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: 15378177
• MDR Text Key: 299454797
• Report Number: 1049092-2022-00364
• 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: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 510827
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• 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