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

Model Number	ULTRA12
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
Event or Problem Description
End user states "she had burning and a uti after use of the ultra12 catheter, used a couple "about a weeks worth" from 1 mu of lot 22b20803.She has been cathing for 2 yrs now 2 x a day as well as voids on own throughout the day.She said it is due to her bladder not emptying." she said "she only used "about a weeks worth" of these cathing and she felt like they were too short for her anatomy to fully drain her.She said she put them "as far as they would go" funnel up to urethra and after she drained, oftentimes 20 min later she felt like she had to void again and then she would void on her own more urine out.She also said it also burned "for just a little while" after she used the catheter and then she would wash herself with soap an water in peri/ urethral area and the burning would go away after cathing.She has no allergies to anything she is aware of to lubricant she just said she had some "allergies to drugs taken by mouth." she mentioned 2-3 days after using these she was diagnosed with a uti.She said she is not sure if it was due to this catheter or not."i don't know if this was just a coincidence" she had urgency, did not feel herself.She did do urine testing and said she was given one antibiotic then it was switched to another antibiotic.She said prior to starting to cath 2 yrs ago she was prone to utis starting in her 30s.This was her first uti while cathing.She is mindful to wash her hands prior to cathing, cleanses her urethral area with soap and water and then is mindful to keep catheter sterile prior to insertion.".
Additional Manufacturer Narrative
A2: sex: female, age: 88.D2a: common device name: catheter, urological.Based on the available information, this event is deemed to be a serious injury.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.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 16867337
• Report Number: 1049092-2023-00061
• Device Sequence Number: 14822253
• Product Code: KOD
• UDI-Device Identifier: 00815947020437
• UDI-Public: 00815947020437
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• 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): 05/01/2023

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 Expiration Date: 07/28/2025
• Device Model Number: ULTRA12
• Device Lot Number: 22B20803
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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