MAUDE Adverse Event Report: COLOPLAST A/S SENSURA1P MX OPCX W EXTRP15/43; OSTOMY BAG

Model Number 1569601400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Swelling (2091); Burning Sensation (2146)

Event Type  Injury  

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 information received, the user indicated samples of 15696 caused irritation and blistering over the entire area of the skin covered by the adhesive barrier.The doctor prescribed ostomy powder and an anesthetic product for the burning sensation she experienced.The user indicated the skin was healing, albeit slowly and no additional treatment, beyond the powder and anesthetic, had been pursued.

• Brand Name: SENSURA1P MX OPCX W EXTRP15/43
• Type of Device: OSTOMY BAG
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, DK-30 50; DA DK-3050
• Manufacturer (Section G): COLOPLAST A/S; coloplast hungary kft; buzavirag ut 15; tatabanya, hu 2800 ; HU 2800
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5946110
• MDR Text Key: 54556124
• Report Number: 3003814961-2016-00004
• 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: consumer
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1569601400
• Device Catalogue Number: 1569601400
• Device Lot Number: 5062691
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/13/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR