MAUDE Adverse Event Report: LAPBAND

Device Problems Material Erosion (1214); Device Operates Differently Than Expected (2913)

Patient Problems Autoimmune Disorder (1732); Erosion (1750); Scarring (2061)

Event Date 08/26/2012

Event Type  Injury  

Event Description

My lap band eroded through my stomach.At the time it wasn't even filled and should not have been putting undo pressure on my stomach.I had to have emergency surgery.I now have permanent scarring and suffer reflux and delayed gastric emptying.In addition, after having the band for about 2 years i began having autoimmune issues.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• MDR Report Key: 4814893
• MDR Text Key: 5929333
• Report Number: MW5042893
• 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: 05/28/2015

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: 05/28/2015
• Patient Sequence Number: 1
• Treatment: TUMS; RANTIDINE; RANTIDINE; PLAQUENIL
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 125