MAUDE Adverse Event Report: ALLERGAN LAP BAND

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663)

Patient Problem Dehydration (1807)

Event Date 10/04/2011

Event Type  Injury  

Event Description

Lap band don't work.It was not "tight" enough for weight loss, it prevented me from eating and drinking anything.Became dehydrated and needed to visit the emergency room for iv fluids and deflation of band.Second surgeon (who removed band) stated that it was placed incorrectly during the original surgery.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5972998
• MDR Text Key: 55608530
• Report Number: MW5064982
• 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: 09/21/2016

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 96