MAUDE Adverse Event Report: COLOPLAST A/S SENSURA URO CLICK MAXI TRP. 50; OSTOMY BAG

Model Number 1185501001

Device Problem No Flow (2991)

Patient Problems Pain (1994); Urinary Retention (2119)

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.However, a recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.

Event Description

According to the available information, a nurse comes twice a day to make treatment : one time on the morning and a second time at evening.One day on the evening, she realized the patent did not move from his bed.Patient said it was because he had pain to kidneys and on the back.There the nurse saw that no urine flowed to the bag, she took off the bag and saw that it was completely welded and urine can't flow into the bag.Outcomes: the pain occurred 4 hours after she put the bag.The pain was only due to no urine flow.The nurse changed the bag.The change of bag relieve patient from pain immediately and urine flow into the new bag- the affected device was disposed and other bags from the retail box was used with no problem.

• Brand Name: SENSURA URO CLICK MAXI TRP. 50
• Type of Device: OSTOMY BAG
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S TATABANYA,; bùzavirág u. 15,; tatabánya, 2800 ; HU 2800
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5792319
• MDR Text Key: 50220976
• Report Number: 3003814961-2016-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1185501001
• Device Catalogue Number: 1185501001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1