FDA Adverse Event
Injury
Summary report: N
LAP BAND AP SYSTEM
MDR report key: 2171312
·
Received July 16, 2011
Report
- Report Number
- MW5021402
- Event Type
- Injury
- Date Received
- July 16, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 16, 2011
- Manufacturer
- ALLERGAN, INC.
- Product Code
- LTI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD AN AP LAP BAND, MFG BY ALLERGAN, PLACED ON (B)(6) 2008. FROM THE BEGINNING, I HAD DIFFICULTY SWALLOWING ALTHOUGH I TOOK PEA-SIZED BITES & CHEWED EVERYTHING TO MUSH. DENSE PROTEIN AND VEGETABLES, IN VEGETABLES, WERE VERY DIFFICULT FOR ME TO SWALLOW. I SUFFERED CHEST PAIN, VOMITING, AND EXCESSIVE SALIVA PRODUCTION AS A RESULT. DATES OF USE: (B)(6) 2008 - (B)(6) 2011. EVENT ABATED AFTER USE : YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP BAND AP SYSTEM | NONE | LTI | ALLERGAN, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |