MAUDE Adverse Event Report: COLOPLAST A/S JJ SIL CH08/12 STENOSTENT 30CM; SILICONE URETHRAL STENT

Model Number AJ4W861002

Device Problem Expiration Date Error (2528)

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.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, the surgeon has informed our sales rep about a surgical intervention happened in (b)(6) 2016.The surgeon was not able to connect the pusher, it fell off immediately, occurred with 2 pusher within the same intervention.He could complete the operation with a 3rd pusher/jj-stent and few delay (less than 30 minutes).The patient was not harmed.We have realized, the product shelf life has been already expired in july 2015! the sales rep will ask the surgeon to pay attention to product expiry dates.

• Brand Name: JJ SIL CH08/12 STENOSTENT 30CM
• Type of Device: SILICONE 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: 6102432
• MDR Text Key: 60415948
• Report Number: 9610711-2016-00034
• 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
• Type of Report: Initial
• Report Date: 11/15/2016

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 Expiration Date: 07/10/2015
• Device Model Number: AJ4W861002
• Device Catalogue Number: AJ4W861002
• Device Lot Number: 3896886
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/15/2016
• 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