MAUDE Adverse Event Report: ALLERGAN LAPBAND

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

I have the allergan lap band and i suffer to much acid reflux and internal bleeding most of the time and lapband side effect.I had it replace, but same issues, so desperate, no health insurance and i need permanent treatment.I had been unable to sleep laying down and drinking acid reflux pills since (b)(6) 2013, side effects never explained.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 3612641
• MDR Text Key: 22137011
• Report Number: MW5034210
• 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: 02/03/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 73