MAUDE Adverse Event Report: COLOPLAST CORP. CONVEEN SECURITY+ EXTERNAL MALE CATHETER, SIZE MEDIUM, PACKAGE:COLOLAST 5230 DIA

Lot Number 6325538

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Date 11/15/2018

Event Type  malfunction  

Event Description

Conveen security+ external male catheter, both products received were faulty, plastic sheath was peeling / delaminating.Coloplast 5230 diam 30mm; lot 63255538.Purchased from (b)(6), order date: (b)(6) 2018.I have a photograph of the peeling plastic and product packaging that i could send if requested.No physical problem, simply reporting device fault.

• Brand Name: CONVEEN SECURITY+ EXTERNAL MALE CATHETER, SIZE MEDIUM, PACKAGE:COLOLAST 5230 DIA
• Type of Device: CONVEEN SECURITY+ EXTERNAL MALE CATHETER, SIZE MEDIUM, PACKAGE:COLOLAST 5230 DIA
• Manufacturer (Section D): COLOPLAST CORP.
• MDR Report Key: 8119776
• MDR Text Key: 129301503
• Report Number: MW5081749
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2021
• Device Lot Number: 6325538
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1