MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH

Lot Number 48063Q

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Bravo capsule detached early based on the uploaded data.There's only 76.45 hours recorded instead of 96 hours.Patient wore the recorder the entire time intended for the study.Informed tech support about the issue.Doctor was made aware.Id# (b)(4) lot # 48063q.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10859926
• MDR Text Key: 216876030
• Report Number: 10859926
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 48063Q
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1