MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW DUFO 3WAY SIL 50ML CH24; SILICONE PROSTATECTOMY CATHETER

Model Number AB63241002

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

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; however, the issue of foreign material contamination is a known risk.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 rollow-up report will be submitted.

Event Description

According to the information received, dirts and/or hairs are found at around the tip of the catheters.

• Brand Name: X-FLOW DUFO 3WAY SIL 50ML CH24
• Type of Device: SILICONE PROSTATECTOMY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la canéda, 24206 ; FR 24206
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6123024987
• MDR Report Key: 5033358
• MDR Text Key: 25013632
• Report Number: 9610711-2015-00028
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144572
• UDI-Public: 03600040144572
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AB63241002
• Device Catalogue Number: AB63241002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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