MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510799
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: tray, catheterization, sterile urethral, with or without catheter (kit).Based on the available information, this event is deemed to be a reportable malfunction.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).
Event or Problem Description
End user's mother states she found "brownish spots on the finger tips of the clear plastic gloves in her cure 10fr catheter kits" that she used to catherize her son.The gloves were discarded, however she said "the school nurse did use them when she cath'd eli when she found them as well but no harm reported.".

• 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
• MDR Report Key: 14104246
• Report Number: 1049092-2022-00212
• Device Sequence Number: 17699457
• Product Code: FCM
• UDI-Device Identifier: 00815947020659
• UDI-Public: 00815947020659
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2024
• Device Model Number: 510799
• Device Lot Number: 210527-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Age: 8
• Patient Sex: Male