MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number 510858

Device Problem Sharp Edges (4013)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Device 58 of 60.Common device name: catheter, urethral.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.(b)(4).

Event Description

End user reports "all the catheters in both boxes (total qty 60 catheters) have rough unpolished eyelets.He said he has used these catheters for years and have never experienced any issues with the eyelets before stating they were always very smooth eyelets going in.He said one can not tell visually tell before inserting or through the packaging but he could only feel it in his urethra "the whole way" going in and out the eyelets felt like they tore him on the inside.No bleeding.He said the pain would go away as soon as the catheter was outside of him.No medical invention sought.After he removed these, he would feel the catheters and noted with his touch that the "rough parts" were indeed by the eyelets, denies anything sticking out of them." he confirmed "he is placing the coude tip upwards properly as well stating he has cath'd for many years 5 x a day and knows the proper technique.He has been using them because that is all he had.".

• 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: 14044340
• MDR Text Key: 288811354
• Report Number: 1049092-2022-00155
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00815947020093
• UDI-Public: 00815947020093
• Combination Product (y/n): N
• PMA/PMN Number: K132500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 510858
• Device Lot Number: 210731-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male