MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Tachycardia (2095); Urinary Tract Infection (2120); Discomfort (2330)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: ultram14 16in straight tip.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 (b)(4).
Event or Problem Description
End user reporting having a uti while using the ultram14 catheters that resulted in a 4 day hospitalization.He said "he is aware with catherization he can put himself at risk for uti.He said he went into the er and was admitted into the hospital last sunday and stayed 4 days diagnosed with a uti after urine testing (ua and urine c & s) done and confirmed uti.He said he knew he had a uti because he had frequency to cath about every 20 min and sudden urgency.His heart was racing about 110 beats per minute as well which was another reason he was admitted.He said his urine was darker looking, denies any blood, and had a fever that he remembers was 100.8f.He is immunocompromised as he has stage 4 cancer multiple myeloma as well.He said they gave him iv antibiotics while he was in the hospital and he is feeling better now.He remembers no issues with the catheters out of his usual discomfort he feels with every kind of brand of catheter placement in his urethra at times that has occurred ever since he started cathing 13 years ago for retention.Nothing he felt was unusual with the catheters themselves or his experience with them prior to cathing prior to his uti.No abnormalities noted on the catheters." end use did state "he is not often mindful of washing his hands prior to cathing.He does not wipe with an antibacterial wipe prior to cathing.He does use the no touch sleeve and makes sure he keeps the catheter sterile when inserting.".

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 14345249
• Report Number: 1049092-2022-00285
• Device Sequence Number: 6322948
• Product Code: EZD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• 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): 05/05/2022

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: 01/28/2025
• Device Model Number: 510814
• Device Lot Number: 220227-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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: Male