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

Model Number	ULTRA16
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer stated she ended up getting a uti she thinks was "brewing for a few weeks" and ended up going to the emergency room last week (b)(6) 2022 as she said she was hyperventilating from anxiety and had felt overall not well for the last few weeks.It was confirmed with urine testing ua and urine culture she had a uti from er.Her only uti symptom was having frequency voiding.She told me she cannot be sure what caused her uti but possibly the ultra16 could have contributed to her uti as she said she thinks because they were so messy and short not draining her bladder all the way as described in the complaint details for this case.She said she may have also touched the entrance to her urethra while cathing with the ultra16 as it was so short with a nail she has that is infected and split and she is ¿treating with a pomade¿.She said sometimes she cannot wash her hands prior to cathing and will use a "99% water" gentle baby wipe to wipe her hands and she also uses one to cleanse urethra prior and after cathing.At er they checked her urine and it was positive for uti and she is finishing up a round of 7 day antibiotics prescribed, she does not know the name of it but is feeling better.She does not get utis often she said.
Additional Manufacturer Narrative
Complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (b)(6).Complainant phone: (b)(6).Patient country: usa.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: (b)(4).Manufacturing site: (b)(4).

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 16240769
• Report Number: 1049092-2023-00013
• Device Sequence Number: 6553018
• Product Code: KOD
• UDI-Device Identifier: 00815947020451
• UDI-Public: 00815947020451
• Combination Product (Y/N): N
• PMA/510(K) Number: K080881
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2023

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: 06/28/2025
• Device Model Number: ULTRA16
• Device Lot Number: 22B12503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: Female