MAUDE Adverse Event Report: REALIZE BAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Dehydration (1807); Scar Tissue (2060); No Code Available (3191)

Event Date 08/21/2014

Event Type  Injury  

Event Description

Lap band prolapsed and caused bruised and scarred stomach tissue.It was fatal had it not been removed immediately.Prior events of dehydration and gastric distress.Manufacturer reported as allergan.

• Brand Name: REALIZE BAND
• Type of Device: REALIZE BAND
• MDR Report Key: 4402921
• MDR Text Key: 5304546
• Report Number: MW5040091
• 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: 01/05/2015

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: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Weight: 113