MAUDE Adverse Event Report: CONVATEC CONVATEC; OSTOMY IRRIGATOR

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  

Event Description

Status past small bowel transplant in 2010.Admit (b)(6) 2016 with fever.Stoma cultured as pt recently changed ostomy supplies.Rhizopus microsporus cultured.Concern mucor infection was possibility attributed to ostomy supplies.

• Brand Name: CONVATEC
• Type of Device: OSTOMY IRRIGATOR
• Manufacturer (Section D): CONVATEC; greensboro NC 27409
• MDR Report Key: 6321700
• MDR Text Key: 67262196
• Report Number: MW5067799
• Device Sequence Number: 0
• Product Code: EXB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/08/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR