MAUDE Adverse Event Report: INAMED LAP-BAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vomiting (2144); Hernia (2240); Ulcer (2274); No Code Available (3191)

Event Date 01/13/2011

Event Type  Injury  

Event Description

My lap band injury involved the creation of a hiatal hernia, along with esophageal ulcers, spasms vomiting blood and an increase in my white blood cell count.The lap band is (inamed 10 cm serial (b)(4)).To prevent further injury i have to have the band removed asap.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• Manufacturer (Section D): INAMED
• MDR Report Key: 3795511
• MDR Text Key: 14880092
• Report Number: MW5035941
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/01/2014

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
• Other Device ID Number: 10 CM SIZE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR