MAUDE Adverse Event Report: LAP BAND

Device Problems Entrapment of Device (1212); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Flatus (1865); Physical Entrapment (2327)

Event Type  Injury  

Event Description

I had severe stomach pain for almost 24 hours, and thinking it was my gallbladder or something, tried to tough it out.I finally had to be rushed to the emergency room, to later learn that the tubing of my lap band had wrapped around my intestines.I had surgery the next morning to undo this.About 6 months later, i learned that my lap band had eroded into my stomach.I feel that this was in part due to having 1.5 liters of fluid in my stomach for almost 1.5 days, pulling down on my stomach when the tubing wrapped around my intestines.Ever since, i've had unusual deep belching, as if there's a pocket in my stomach collecting air.Two of my friends are also having difficulty with their bands.This product should be recalled!.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 3651145
• MDR Text Key: 18302971
• Report Number: MW5034720
• Device Sequence Number: 1
• Product Code: LTI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 37 YR