MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP BAND

Device Problem Mechanical Problem (1384)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/09/2016

Event Type  Injury  

Event Description

Had a lap band for 12 years and had to have emergency surgery to have it removed.I was nearly completely obstructed and unable to eat or drink.If left alone it would have been fatal.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 6642931
• MDR Text Key: 77759304
• Report Number: MW5070417
• Device Sequence Number: 1
• Product Code: LTI
• 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: 06/14/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2017
• 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: 91