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

Model Number RSM101

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

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 10/21/2017

Event Type  Injury  

Event Description

Post-op esophageal injury during balloon retrieval procedure on (b)(6) 2017.Post removal patient complained of mild cramping on right scapula.Physician offered to do x-ray or ct scan, but patient refused.Patient visited hospital on (b)(6) 2017 and was admitted for ct scan and observation due to possible esophageal laceration - no surgical intervention was required.Patient was sent home 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: 7047210
• MDR Text Key: 92584139
• Report Number: 3007934906-2017-00036
• 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: 11/16/2017

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: 10/31/2017
• Device Model Number: RSM101
• Device Catalogue Number: 01-0011-001
• Device Lot Number: 161031-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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): Hospitalization
• Patient Age: 69 YR