MAUDE Adverse Event Report: ALLERGAN LAP-BAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 06/18/2015

Event Type  Injury  

Event Description

I had the lapband in (b)(6) 2011.Almost immediately there were issues.I kept quiet as long as i could, but in 2015 i could no longer take the pain.I couldn't eat anything, i was constantly throwing up foam, and was serious.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5580888
• MDR Text Key: 42869657
• Report Number: MW5061711
• 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: 04/12/2016

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73