FDA Adverse Event
Malfunction
Summary report: N
LARYNGEAL MASK AIRWAY
MDR report key: 348225
·
Received August 17, 2001
Report
- Report Number
- 9681900-2001-00051
- Event Type
- Malfunction
- Date Received
- August 17, 2001
- Report Date
- June 11, 2001
- Manufacturer
- THE LARYNGEAL MASK COMPANY
- Product Code
- CAE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
AN ARTICLE WAS EVALUATED AND DISPOSITIONED BY LMA NORTH AMERICA, INC. MEDICAL AFFAIRS DEPARTMENT. THIS CASE INVOLVED A LMA AIRWAY THAT WAS USED IN PATIENT IN FOREIGN COUNTRY. THIRTY MINUTES INTO THE CASE, THE CUFF WAS HEARD TO BURST. THE RUPTURED CUFF WAS SEEN ON REMOVAL OF THE LMA AIRWAY. ANOTHER LMA AIRWAY WAS INSERTED AND THERE WAS NO PATIENT INJURY OR COMPLICATIONS. SINCE THIS INFORMATION WAS OBTAINED FROM A LITERATURE ARTICLE, THE DEVICE WILL NOT BE RETURNED AND NO ADDITIONAL INFORMATION IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37807 | LARYNGEAL MASK AIRWAY | OROPHARYNGEAL AIRWAY | CAE | THE LARYNGEAL MASK COMPANY | LMA-CLASSIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |