BRAVO PH MONITORING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for BRAVO PH MONITORING manufactured by Given Imaging Inc..

Event Text Entries

[87346886]
Patient Sequence No: 1, Text Type: N, H10

[87346887] The bravo ph monitoring capsule was not in the area expected when the endoscope was inserted to confirm placement. The physician was unable to determine the reason the bravo ph monitoring capsule did not attach to the esophagus. The bravo ph monitoring capsule was visible in the back of the throat and was retrieved by the physician. Another bravo ph monitoring capsule was prepared and attached to the esophagus. No untoward patient effects.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6893491
• MDR Report Key: 6893491
• Date Received: 2017-09-26
• Date of Report: 2017-09-01
• Date of Event: 2017-08-31
• Report Date: 2017-09-01
• Date Reported to FDA: 2017-09-01
• Date Reported to Mfgr: 2017-09-01
• Date Added to Maude: 2017-09-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: BRAVO PH MONITORING
• Generic Name: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Product Code: FFT
• Date Received: 2017-09-26
• Lot Number: 356640
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: GIVEN IMAGING INC.
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Device Sequence Number: 1

• Brand Name: BRAVO PH MONITORING
• Generic Name: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Product Code: FFX
• Date Received: 2017-09-26
• Lot Number: 356640
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GIVEN IMAGING INC.
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-26