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

Model Number 01-0011-001

Device Problems Deflation Problem (1149); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Cramps (2543); No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

Patient called practice with complaint of abdominal pain on (b)(6) 2017 which was 142 days post-placement.Patient was seen in the office on (b)(6) and an x-ray was done which showed that the balloon unit had deflated and had migrated from the stomach.The patient was sent home and told to monitor stool to determine if balloon had passed in stool.The ballon unit was surgically removed from the large intestine on (b)(6) 2017 without complication and the patient was discharged on (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: 7155047
• MDR Text Key: 96124305
• Report Number: 3007934906-2017-00038
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/11/2018
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 170420-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2017
• 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: 40 YR