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

Model Number FGS-0634

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  malfunction  

Event Description

We have 2 bravo recorders.I noticed that one of our bravo recorders was not uploaded.I uploaded it and then found that we had uploaded a previous patient's study twice from the other bravo recorder (this was determined by the bravo capsule number).We inadvertently re-uploaded a previous study and put someone's name on the study, thinking it was hers.

• Brand Name: BRAVO REFLUX RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17885384
• MDR Text Key: 325080699
• Report Number: 17885384
• 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: 08/28/2023,08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-0634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2023
• Date Report to Manufacturer: 10/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA