MAUDE Adverse Event Report: UNKNOWN; IMPLANT OBESITY

Device Problem Material Erosion (1214)

Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812)

Event Date 01/10/2016

Event Type  malfunction  

Event Description

Patient c/o abdominal pain.Egd confirmed erosion of gastric band into stomach.Surgery to remove gastric band confirmed erosion into stomach and large abscess pocket with creamy pus in and around subcutaneous port.

• Type of Device: IMPLANT OBESITY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5494620
• MDR Text Key: 40133771
• Report Number: 5494620
• Device Sequence Number: 0
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2016
• Date Report to Manufacturer: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 104