FDA Adverse Event Injury Summary report: N

REALIZE

MDR report key: 4080794 · Received September 5, 2014

Report

Report Number
MW5038108
Event Type
Injury
Date Received
September 5, 2014
Report Date
September 5, 2014
Product Code
LTI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE BAND INSERTED IN (B)(6) 2008. AFTER ONE YEAR, I HAVE CONSTANT VOMITING. ENDED UP NOT BEING ABLE TO SWALLOW WATER AND HAD TO HAVE IT REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
543262 REALIZE GASTRIC BAND LTI * *

Patients

Seq Age Sex Outcome Treatment
1 36 YR Required Intervention