MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510856
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 he used qty 75 catheters cure m12c from unknown market units that were difficult for him to use when inserting in his urethra, did not glide in well felt like he was meeting resistance with every use, leading him to have a uti." he attempted to use m12c for about the last few weeks as he caths 4-5 x a day and noted difficulty passing in his urethra and often he had to touch the catheter "forcing it to go in" to drain his bladder.He uses lubrication prior to insertion, familiar with proper coude placement.He does cleanse his meatal opening with a antibacterial wipe prior to insertion.He does not always wash his hands prior to use.He is paralyzed from the waist down and has no feeling when cathing.Yesterday he was not feeling well, overall rundown and said he had cold like symptoms and fever.He often feels this way when he has a uti.He went into his er and they ran a ua which was positive for possible infection and he said the urine culture is still in process.He was prescribed levaquin antibiotic and he has yet to pick it up.End user was advised him to not use these catheters and was reminded of hand hygiene prior to use and proper clean intermittent catheterization technique.This emdr covers the unknown number of catheters associated with the uti.

• 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: 13802688
• Report Number: 1049092-2022-00087
• Device Sequence Number: 4994300
• Product Code: EZD
• UDI-Device Identifier: 00815947020079
• UDI-Public: 00815947020079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132500
• 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): 03/09/2022

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: 09/28/2026
• Device Model Number: 510856
• Device Lot Number: 211015-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• 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