FDA Adverse Event
Malfunction
Summary report: N
ENVUE
MDR report key: 20211880
·
Received September 13, 2024
Report
- Report Number
- 20211880
- Event Type
- Malfunction
- Date Received
- September 13, 2024
- Date of Event
- March 7, 2024
- Report Date
- July 17, 2024
- Manufacturer
- ENVIZION MEDICAL LTD
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DOBHOFF STYLET UNABLE TO BE REMOVED FROM DOBHOFF AFTER INSERTION INTO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1113808 | ENVUE | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | ENVIZION MEDICAL LTD | K23C064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |