MAUDE Adverse Event Report: WILSON COOK MEDICAL INC BRODMERKEL COLON DECOMPRESSION DEVICE

Model Number CDSB-7

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2014

Event Type  Injury  

Event Description

During the removal of a brodmerkel colon decompression tube, the pt "suddenly grabbed the tube mid withdrawal; snapping it inches out from anus".

• Brand Name: BRODMERKEL COLON DECOMPRESSION DEVICE
• Type of Device: COLON DECOMPRESSION DEVICE
• Manufacturer (Section D): WILSON COOK MEDICAL INC; winston salem 27105
• MDR Report Key: 3905791
• MDR Text Key: 18001897
• Report Number: MW5036905
• Device Sequence Number: 1
• Product Code: FEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDSB-7
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR