FDA Adverse Event
Injury
Summary report: N
LINX REFLUX MANAGEMENT SYSTEM
MDR report key: 3232022
·
Received July 4, 2013
Report
- Report Number
- 3008766073-2013-00021
- Event Type
- Injury
- Date Received
- July 4, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 10, 2013
- Manufacturer
- TORAX MEDICAL INC.
- Product Code
- LEI
- PMA / PMN Number
- 100049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306714 | LINX REFLUX MANAGEMENT SYSTEM | LEI | TORAX MEDICAL INC. | LS13 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| S |