MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0313

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Nausea (1970); Vomiting (2144); Chills (2191); Radiation Exposure, Unintended (3164)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient underwent an esophagogastroduodenoscopy (egd) procedure for gastroesophageal reflux disease using a ph monitoring device.The following day, the patient experienced lower abdominal discomfort and diarrhea.The next day, the patient presented to the emergency department with abdominal pain and worsening right lower quadrant (rlq) pain.The patient complained of nausea, vomiting, chills, and loose stool.The patient was afebrile with stable vital signs.Laboratory results showed high white blood count (wbc).A computerized tomogram (ct) of the abdomen and pelvis revealed perforated appendicitis and a right kidney mass suspicious for neoplasm.The patient was admitted to the hospital for perforated appendicitis.The patient developed a fever while hospitalized.The patient was treated with intravenous antibiotics, pain medication, and diet.Six days later, the patient was discharged from the hospital on oral antibiotics.Seven weeks later, he patient underwent another ct scan which revealed the same right kidney mass.The patient is expected to undergo surgery for appendectomy and right kidney mass removal.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8746187
• MDR Text Key: 149624594
• Report Number: 9710107-2019-00297
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 101