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

Model Number PHZ-BRAVO100

Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/28/2023

Event Type  Injury  

Event Description

Bravo device failed to deploy due to malfunction which caused bleeding from distal esophagus and hospital admission.

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 17228211
• MDR Text Key: 318289347
• Report Number: MW5118954
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PHZ-BRAVO100
• Device Catalogue Number: FGS-0635
• Device Lot Number: 58540F
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White