MAUDE Adverse Event Report: UNKNOWN GASTRIC BAND PORT; GASTRIC IMPLANT OBESITY

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Diagnostic laparoscopy indicated flipped port of the gastric band, malpositioned in need of port replacement.

• Brand Name: GASTRIC BAND PORT
• Type of Device: GASTRIC IMPLANT OBESITY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5067000
• MDR Text Key: 25346115
• Report Number: 5067000
• Device Sequence Number: 1
• 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
• Report Date: 09/08/2015

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2015
• Device Age: 1 YR
• Date Report to Manufacturer: 09/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 121