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

Model Number	F14NC
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
Consumer reports "she sometimes gets utis with use of catheters, of an unknown qty, unknown mus and unknown lots.Consumer reports that she washes and reuses her usual f14nc catheters and this caused her a uti.She has always used the catheter f14nc and it has worked well for her able to get them in to drain easily.She has never needed to use lube she said.She said soon after she started using the f14nc catheters she would wash and re-use she would "sanitize by soaking them in alcohol" she felt like her urgency, burning and just bladder pain kept getting worse and she knew she had a uti.Her pcp placed an order for her to go the lab for a urine sample and she was then prescribed on a course of 5 days of antibiotics (name unknown) which she is still finishing up and feeling "a little bit better." she admits she has had many utis and the last one she remembers being about 2 months ago with the same symptoms and she needed to undergo lab testing (ua and urine culture and needed antibiotics then too.) she said she thinks she gets these utis because she admits to often washing and reusing her catheters because she needs more than what they will give her in supplies.She said she feels like she has to cath 14 times a day often now getting out very small amounts and this feeling to cath has increased from the prior years.She thought this is a normal part of getting older.She said she hasn't gone into see her urologist in 1-2 years because she thought she didn't' have to be seen anymore due to her age in her 80s." this emdr covers the unknown number of catheters associated with the uti.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• 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: 18229454
• Report Number: 1049092-2023-00323
• Device Sequence Number: 5673943
• Product Code: EZD
• UDI-Device Identifier: 00815947020246
• UDI-Public: 00815947020246
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: EXEMPT
• 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): 11/16/2023

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 Model Number: F14NC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/29/2023
• 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: Unknown