BRAVO PH CAPSULE DELIVERY DEVICE

Report

• Report Number: 9710107-2015-00266
• Event Type: Death
• Date Received: November 26, 2015
• Report Date: October 26, 2015
• Manufacturer: GIVEN IMAGING LTD
• Product Code: FFT
• PMA / PMN Number: K102543
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INITIAL REPORT DATE: 11/25/2015. INITIAL REPORTER ALSO SENT REPORT TO FDA, (REPORT #: MW5044841) UNFORTUNATELY, THE INITIAL REPORTER IS UNABLE TO RELEASE ANY FURTHER INFORMATION THAT PERTAINS TO THE REPORT IN QUESTION. THEREFORE, NO ADDITIONAL INFORMATION FOR THIS REPORT IS AVAILABLE

Description of Event or Problem · 1

IT WAS REPORTED THAT AN AUTISTIC INDIVIDUAL WITH A HISTORY OF CONSTIPATION BECAME UNRESPONSIVE. THE PATIENT WAS RUSHED TO THE EMERGENCY ROOM AND PRONOUNCED DEAD. DURING THE AUTOPSY A PERFORATION WAS FOUND IN THE CECUM. A BRAVO CAPSULE WAS FOUND IN THE CECUM ADJACENT TO THE PERFORATION SITE. THE PERITONEAL CAVITY CONTAINED BLOOD AND FECAL MATTER. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
782444	BRAVO PH CAPSULE DELIVERY DEVICE	ELECTRODE, PH, STOMACH	FFT	GIVEN IMAGING LTD	FGS-0313

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death

Terms

Patient problem · 2

• Death
• Perforation

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• OTHER