MAUDE Adverse Event Report: GASTRIC LAP BAND

Device Problem Material Erosion (1214)

Patient Problems Gastritis (1874); Pain (1994)

Event Date 04/01/2017

Event Type  Injury  

Event Description

I had a lap band that eroded 80% into lumen of my stomach.Having it removed on (b)(6) 2018.Severe gerd and pain.

• Brand Name: GASTRIC LAP BAND
• Type of Device: GASTRIC LAP BAND
• MDR Report Key: 7112240
• MDR Text Key: 94899292
• Report Number: MW5073952
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 95