MAUDE Adverse Event Report: COLOPLAST A/S JJ SI O/O DIR WO GD CH06 28CM; URETERAL STENT

Model Number AJ4C651002

Device Problem Expiration Date Error (2528)

Patient Problem No Code Available (3191)

Event Date 01/23/2018

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, it was reported by tm that product with expiration date of 3/2017 was shipped to a customer; however, when customer service looked up the lot number, the expiration date in the system said 7/2020.No product was implanted.

• Brand Name: JJ SI O/O DIR WO GD CH06 28CM
• Type of Device: URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE; 9 avenue edmond rostand; sarlat-la-caneda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 7230571
• MDR Text Key: 98861507
• Report Number: 9610711-2018-00002
• 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: company representative,user f
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AJ4C651002
• Device Catalogue Number: AJ4C651002
• Device Lot Number: 4711107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 01/31/2018
• 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: N
• Patient Sequence Number: 1