MAUDE Adverse Event Report: ALLERGAN ADJUSTABLE GASTRIC BAND

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Prolapse (2475)

Event Date 11/13/2013

Event Type  Injury  

Event Description

Four hospital admissions.Gastric band was empty but still unable to swallow.Band prolapsed on stomach.Removed (b)(6) 2015.

• Brand Name: ADJUSTABLE GASTRIC BAND
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5795371
• MDR Text Key: 49664593
• Report Number: MW5063405
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2016

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 25 YR
• Patient Weight: 139