MAUDE Adverse Event Report: RESHAPELIFESCIENCES 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	Nausea (1970); Vomiting (2144)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had visited the emergency room twice with discomfort and nausea and was admitted to the hospital once with the same symptoms.Reshape lifesciences customer service reached out to the practice and spoke with the physician directly and he stated the patient had an appointment this week complaining of nausea, vomiting, and mentioned the food tends to sit in the esophagus and causes discomfort.During the appointment, the patient stated they were taking ibuprofren; however, the physician asked the patient not to take ibuprofren anymore and prescribed another medication.The physician also noted the patient has depression and thought this was exasperated due to the condition.The patient reportedly had the balloons removed on (b)(6) 2018.
Additional Manufacturer Narrative
The product in question was originally to return; however, the product was never returned to reshape lifesciences.Updated mdr to reflect this change.
Event or Problem Description
The patient had visited the emergency room twice with discomfort and nausea and was admitted to the hospital once with the same symptoms.Reshape lifesciences customer service reached out to the practice and spoke with the physician directly and he stated the patient had an appointment this week complaining of nausea, vomiting, and mentioned the food tends to sit in the esophagus and causes discomfort.During the appointment, the patient stated they were taking ibuprofen; however, the physician asked the patient not to take ibuprofen anymore and prescribed another medication.The physician also noted the patient has depression and thought this was exasperated due to the condition.The patient reportedly had the balloons removed on (b)(6) 2018.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPELIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7577936
• Report Number: 3007934906-2018-00020
• Device Sequence Number: 2011868
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: Physician
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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