MAUDE Adverse Event Report: COLOPLAST A/S JJ SI O/O DIR FIX CO CH07 16; SILICONE DOUBLE LOOP URETHRAL STENT

Model Number AJ42711002

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

No sample or lot number was provided.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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

In the retail box aj4271 catheter 7/26 instead of 7/16.

• Brand Name: JJ SI O/O DIR FIX CO CH07 16
• Type of Device: SILICONE DOUBLE LOOP URETHRAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-canéda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6083452
• MDR Text Key: 59572608
• Report Number: 9610711-2016-00030
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K013921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AJ42711002
• Device Catalogue Number: AJ42711002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1