MAUDE Adverse Event Report: ALLERGAN/APOLLO ENDOSURGERY, INC. LAP-BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/15/2013

Event Type  Injury  

Event Description

Allergan lap-band slipped, creating a blockage in the esophagus.I could not swallow anything, even my own saliva.There was no fluid in the band at that time so no adjustment could be made to manipulate the band.I was admitted to the hospital and had to undergo emergency surgery to remove it at full cost.The removal procedure was not covered by insurance.The surgeon said removal could not wait as the band could perforate the stomach, which is life-threatening.Fda safety report id # (b)(4).

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN/APOLLO ENDOSURGERY, INC.
• MDR Report Key: 9539508
• MDR Text Key: 173770839
• Report Number: MW5091978
• 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: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 75