MAUDE Adverse Event Report: COLOPLAST A/S CONVEEN OPTIMA 35Ø; MALE EXTERNAL CATHETER-UROSHEATH

Model Number 2203501017

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583); Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the information received, when the patient tried "conveen optima" for the first time, he did not seem to have a problem with the adhesivity of the product.He tried 22030 but finally opted for 22035 because he found the 22030 too tight.When he tried to remove the urisheath, it was impossible to do so.The doctor had to come to remove the uristheath with scissors and a pincet.Unfortunately, the urisheath was stuck so much that the skin came off.This happened on (b)(6).Today the patient is not using the urisheaths anymore trying to let his skin heal.An appointment with the rep was made, unfortunately, it was cancelled by the patient's son because the patient was terminal - no further information regarding this.

• Brand Name: CONVEEN OPTIMA 35Ø
• Type of Device: MALE EXTERNAL CATHETER-UROSHEATH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S NYIRBATOR; coloplast utca 2; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6123024987
• MDR Report Key: 5112333
• MDR Text Key: 27106311
• Report Number: 3006606901-2015-00017
• Device Sequence Number: 1
• Product Code: EXJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2020
• Device Model Number: 2203501017
• Device Catalogue Number: 2203501017
• Device Lot Number: 4722179
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR