MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number	01-0011-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon was inserted on (b)(6) 2018.Thirty-six hours later, the patient was hospitalized with severe nausea, vomiting and abdominal pain right after the placement of the balloon.During the removal of the balloon, the physician noted a lot of fluid in the stomach and the fluid was not emptying which was probably causing the severe symptoms.Once the balloon was removed, the symptoms resolved immediately.
Additional Manufacturer Narrative
Report received via medwatch mw5078583.
Event or Problem Description
The balloon was inserted on (b)(6) 2018.Thirty-six hours later, the patient was hospitalized with severe nausea, vomiting and abdominal pain right after the placement of the balloon.During the removal of the balloon, the physician noted a lot of fluid in the stomach and the fluid was not emptying which was probably causing the severe symptoms.Once the balloon was removed, the symptoms resolved immediately.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7781192
• Report Number: 3007934906-2018-00031
• Device Sequence Number: 1012947
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention