FDA Adverse Event
Injury
Summary report: N
PORTEX ENDOTRACHEAL TUBES SACETT
MDR report key: 13343081
·
Received January 25, 2022
Report
- Report Number
- 3012307300-2022-01600
- Event Type
- Injury
- Date Received
- January 25, 2022
- Date of Event
- December 1, 2021
- Report Date
- January 25, 2022
- Manufacturer
- NULL
- Product Code
- QCX
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT WHEN THE CUSTOMER WAS TRYING TO REMOVE THE PRODUCT FROM THE PATIENT, THE CUFF GOT CAUGHT IN THE TRACHEA. THE PRODUCT WAS REMOVED BY MAKING AN INCISION IN THE TRACHEA. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702435 | PORTEX ENDOTRACHEAL TUBES SACETT | RETROGRADE INTUBATION SET | QCX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |