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