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

Model Number FGS-0313

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Patient 4 of 4 who complained of chest pain for up to 2-3 days after esophageal bravo ph capsule placement.All 4 patients had capsules from the same lot number.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8945008
• MDR Text Key: 155970279
• Report Number: 8945008
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44441Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Weight: 64