MAUDE Adverse Event Report: GIVEN IMAGING, INC. BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0312

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

When opening the bravo capsule packaging, we checked the water balloon to make sure it had not dried out.The balloon was dry and it was unusable.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12149212
• MDR Text Key: 260982240
• Report Number: 12149212
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 48071Q
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA