FDA Adverse Event
Injury
Summary report: N
MEDOVATIONS INNERVISION DETACHABLE TIPS 50F
MDR report key: 8253670
·
Received January 15, 2019
Report
- Report Number
- MW5083164
- Event Type
- Injury
- Date Received
- January 15, 2019
- Date of Event
- May 16, 2018
- Report Date
- July 6, 2018
- Manufacturer
- MEDOVATIONS INNERVISION / DIVERSATEK HEALTHCARE, INC.
- Product Code
- FAT
- UDI-DI
- 00816734021293
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A 50F BOUGIE TIP BECAME DISLODGED FROM THE ILLUMINATION CORD IN THE PATIENT¿S ESOPHAGUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44455 | MEDOVATIONS INNERVISION DETACHABLE TIPS 50F | 50F BOUGIE TIP / DETACHABLE BOUGIE TIP | FAT | MEDOVATIONS INNERVISION / DIVERSATEK HEALTHCARE, INC. | 1465-50 | 221575 | 00816734021293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |