MAUDE Adverse Event Report: RESHAPE MEDICAL INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number 01-0011-001

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

Patient Problems Nausea (1970); Vomiting (2144); Abdominal Cramps (2543)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Patient complained of upper abdominal pain and vomiting for approximately 24 hours.Patient visited hospital on (b)(6) 2017 for an outpatient ct scan and office evaluation after patient called on same day.Per md, one week of worsening upper abdominal pain, nausea/vomiting.Ct scan showed distal balloon larger than proximal balloon with air fluid levels.The balloon was removed the next morning on (b)(6) 2017.The proximal balloon was visibly larger than when placed and visible air fluid interface - uneventful removal.Patient was compliant with taking their ppi's.Date of insertion: (b)(6) 2017.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: lisa maloney ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9494296680
• MDR Report Key: 7077449
• MDR Text Key: 93841040
• Report Number: 3007934906-2017-00037
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

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
• Device Operator: Physician
• Device Expiration Date: 05/24/2018
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 160622-001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2017
• 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): Other
• Patient Age: 57 YR