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 |