MAUDE Adverse Event Report: C.R. BARD, INC. DIGNISHIELD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 04/11/2018

Event Type  malfunction  

Event Description

Dignishield in use when it popped out fully inflated and a peri-anal mucosal pressure injury was noted.Dignishield not replaced, barrier ointment used and external fecal pouch applied.

• Brand Name: DIGNISHIELD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7468156
• MDR Text Key: 106731086
• Report Number: 7468156
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other