MAUDE Adverse Event Report: ALLERGAN LAPBAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Sjogren's Syndrome (2073)

Event Date 11/05/2015

Event Type  Injury  

Event Description

Multiple autoimmune diseases, that came in suddenly and severe following lap bad installation.Rheumatoid arthritis, sjogrens, gastroparesis, dysphagia, food and skin allergies, chronic widespread inflammation.Band was removed (b)(6) 2015.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5221825
• MDR Text Key: 31197512
• Report Number: MW5057841
• 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: 11/09/2015

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 122