MAUDE Adverse Event Report: OBALON THERAPEUTICS INC. OBALON

Model Number OBALON

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Nausea (1970); Vomiting (2144); Ulcer (2274)

Event Date 07/27/2017

Event Type  Injury  

Event Description

Patient had three obalon balloons placed on (b)(6) 2017 uneventfully.On (b)(6) 2017 patient reported abdominal pain, nausea, and vomiting and thought she had gastroenteritis.On (b)(6) 2017 patient underwent removal of balloons and only two balloons present in the stomach.Large 3 cm ulcer seen in third portion of the duodenum.Fluoroscopy revealed balloon in lower abdomen.Ct scan a couple of hours later revealed balloon in right colon.

• Brand Name: OBALON
• Type of Device: OBALON
• Manufacturer (Section D): OBALON THERAPEUTICS INC. ; carlsbad CA 92008
• MDR Report Key: 6753714
• MDR Text Key: 81501726
• Report Number: MW5071294
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OBALON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 83