MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Material Integrity Problem (2978)

Patient Problems Diarrhea (1811); Fatigue (1849); Headache (1880); Vomiting (2144); Patient Problem/Medical Problem (2688); Constipation (3274)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Reporter stated that she wants the device out of her body and her money back.Doctors would not explant this device and she is constantly experiencing symptoms such as extreme fatigue, belching, headaches, vomiting, constipation, diarrhea, reflux throughout the day.Reporter further indicated that these symptoms are getting worst and more intensified as time goes.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC
• MDR Report Key: 8252815
• MDR Text Key: 133332320
• Report Number: MW5083117
• 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: Patient
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 79