MAUDE Adverse Event Report: LAP BAND

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Sticking (1597)

Patient Problems Chest Pain (1776); Vomiting (2144); Hernia (2240)

Event Date 07/14/2011

Event Type  Injury  

Event Description

Had lap band surgery.Tube became loose and is sticking up.Had caused a hernia.Have trouble eating also band slipped.I cannot go one day without vomiting at least 3 times.Sex is not what it used to be because always have hand over area.I cannot have surgery to fix problem yet blood platelets are extremely low.Too big risk dr.Says right now.About to check platelets again very soon.Hernia getting worse.I have pain in back and chest when i eat.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 5149174
• MDR Text Key: 28355089
• Report Number: MW5056961
• 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
• Report Date: 10/06/2015

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 90