MAUDE Adverse Event Report: COLOPLAST A/S MIO FLEX 70MM 50-68; BASEPLATE

Model Number 1057301400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 01/28/2017

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.In addition, the product information was not available at the time of the complaint.Therefore, item number used was entered into the trackwise complaint handling system to open the complaint.The complaint will be updated if the item number or lot number information becomes available.The only information available was that this was a 50 mm flange from coloplast and that a convatec ostomy irrigator was also involved.

Event Description

According to the available information (medwatch 5067799) patient hospitalization; required intervention.Past small bowel transplant in 2010.Admit 2016 with fever.Stoma cultured as patient recently changed ostomy supplies.Rhizopus microsporus cultured.Concern mucor infection was possibly attributed to ostomy supplies.

• Brand Name: MIO FLEX 70MM 50-68
• Type of Device: BASEPLATE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S THISTED,; coloplast a/s thisted,; industrivej 7, 7700 thisted,; DA
• Manufacturer Contact: christine buckvold
• MDR Report Key: 6419264
• MDR Text Key: 70391002
• Report Number: 9610694-2017-00001
• 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: other
• Type of Report: Initial
• Report Date: 03/20/2017

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: 1057301400
• Device Catalogue Number: 1057301400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/20/2017
• 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
• Patient Outcome(s): Other