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

Model Number	F16
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
Age: 80 years.Common device name: catheter, straight.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.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
End user states "she has been cathing for 5 x a day for years now for retention from a cyst/ growth found on opening of bladder.She was used to using the magic 3 go catheter that always worked well for her but is now on backorder.She said a few weeks ago when she first started using this catheter she was sent by her supplier, she noted they were a "little bit uncomfortable" going in at first and then the discomfort stopped with use she said and then shortly after that she got her uti symptoms.She said she her uti symptoms were ¿discomfort, a little bit itchy and burning.¿ she called into her provider and they prescribed an oral course of antibiotics ciprofloxacin over the phone for her.She did not go into lab or provide a urine sample as she said her town had a covid outbreak so she did not go anywhere nor did her md require urine testing for the ciprofloxacin.She said that antibiotic worked right away which she was grateful for as she said she has sulfa allergies and penicillin allergies.She said this was the first uti she has ever had in her life." she further states she "washes her hands with antibacterial soap prior, does not touch the catheter tubing that goes into her with her hands, holds onto funnel and makes sure it stays sterile prior to insertion.She said she did not apply lubricant at all with use of this catheter stating it was ¿too messy.¿ she also did cleanse her urethra prior to cathing with a ¿regular wipe¿ she buys not antibacterial.She said these were of the appropriate length for her urethra.She is feeling much better now.She said she was sent an alternative catheter, cannot relay name/brand, that is working for her from her supplier.She has already discontinued use of the f16.".

• Brand Name: CURE PRODUCTS
• Common Device Name: 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: 16639970
• Report Number: 1049092-2023-00041
• Device Sequence Number: 14787409
• Product Code: EZD
• UDI-Device Identifier: 00815947020222
• UDI-Public: 815947020222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/20/2023

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: F16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 03/29/2023
• 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: Female