MAUDE Adverse Event Report: COLOPLAST COMPANY MALE EXTERNAL CATHETER

Lot Number 3295673

Device Problems Failure To Adhere Or Bond (1031); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Coloplast company male external catheter ref# 5210 lot # 3295673.Had 15 complete failures of this product in under 4 hrs on (b)(6) 2014.Including one incident where i watched the catheter unravel before i could hook the catheter up to it.This is a product that's supposed to allow male para and quadriplegics to interact with the public like watch a movie at theater and conduct business.I want the govt to investigate as i believe the company shortchanged the amount of glue they were supposed to use in this product.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): COLOPLAST COMPANY
• MDR Report Key: 3612640
• MDR Text Key: 17989874
• Report Number: MW5034209
• Device Sequence Number: 1
• Product Code: NNX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3295673
• Patient Sequence Number: 1
• Patient Weight: 73