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 Abdominal Pain (1685); Fever (1858); Internal Organ Perforation (1987); Perforation (2001); Tachycardia (2095)

Event Date 12/31/2017

Event Type  Injury  

Event Description

Patient had uneventful balloon placement on (b)(6) 2017 and presented to hospital with abdominal pain, fever, and tachycardia on (b)(6) 2017.Exploratory surgery identified the presence of a stomach perforation which was successfully repaired.An upper gi was performed on (b)(6) 2018 and confirmed successful repair.

• 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 igelsia; san clemente, CA 92672 ; 9494296680
• MDR Report Key: 7243130
• MDR Text Key: 99068353
• Report Number: 3007934906-2018-00003
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• 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: 02/02/2018

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
• Device Operator: Physician
• Device Expiration Date: 04/04/2017
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 160407-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR