MAUDE Adverse Event Report: ALLERGAN / APPOLLO ENDOSURGERY LAP BAND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vomiting (2144); Weight Changes (2607)

Event Type  Injury  

Event Description

I had the lap band installed on (b)(6) 2009 and have had nothing but problems since.My insurance does not cover problems with previous lap band surgery, so i have to just bear it.I have port pain, frequent vomiting and reflux, trouble swallowing, weight regain, and lack of info given to me at time of surgery.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN / APPOLLO ENDOSURGERY
• MDR Report Key: 6529854
• MDR Text Key: 74167345
• Report Number: MW5069423
• 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: 04/26/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMBIEN; FLEXERIL
• Patient Outcome(s): Disability
• Patient Weight: 95