MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	CS14
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
A2: sex: male, age: 56.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
End user, 56 year old paraplegic, reports "about 6-7 months he had his initial experience with defected dried up/ thick lubricant in a case of the cs14 catheters." he did not report the issue at that time but has received another case with same defect in a recent order.When he first starting experiencing the defected dried lubricant those 6-7 months ago from that case he didn't know what was wrong at first.He thought maybe he was just dehydrated.He said he felt a lot of "drag" in urethra with insertion and retraction from catheters in this case which caused irritation/ urethritis.He said his symptoms of urethritis kept getting worse with each cath so he went to the md and they did a urine sample and he said "it wasn't a full blown infection" but it was just the start of one.He took pyridium for 2 days and he said he switched to tylenol and then did complete a 10 days worth of antibiotics prescribed by the md and his symptoms had gone away quickly.By that time he was done with the case of catheters and it was only when he started on a new case is when he noticed the feeling of the lubricant being much more slippery, much better like what he was used to and caused no drag at all.He thinks the lubricant on the catheters that caused the irritation was to blame for his symptoms at the time.".

• Brand Name: CURE PRODUCTS
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• 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: 17583442
• Report Number: 1049092-2023-00240
• Device Sequence Number: 4880590
• Product Code: FCM
• UDI-Device Identifier: 00815947020673
• UDI-Public: 00815947020673
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2023

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: CS14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/21/2023
• 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