FDA Adverse Event
Malfunction
Summary report: N
ROBERTAZZI NASAL AIRWAY SIZE 32FR
MDR report key: 1380359
·
Received February 27, 2009
Report
- Report Number
- 8040412-2009-00008
- Event Type
- Malfunction
- Date Received
- February 27, 2009
- Date of Event
- April 2, 2009
- Report Date
- April 21, 2009
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
INCIDENT RECEIVED VIA MEDWATCH. THE EVENT IS REPORTED AS: SEVERAL DAYS POST-OP, A FEMALE PT COMPLAINED OF SORE THROAT AND WHISPERED SPEECH. PT WAS SEEN BY THE MEDICAL RESIDENT AND NOTHING WAS FOUND. AN ATTENDING DOCTOR FOUND GREEN TUBING IN THE PT'S NASOPHARYNX. CONSCIOUS SEDATION WAS ADMINISTERED AND NASAL TRUMPET WAS REMOVED. PT RECOVERED AND COMPLAINT RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROBERTAZZI NASAL AIRWAY SIZE 32FR | NASAL AIRWAY | BTQ | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |