FDA Adverse Event
Malfunction
Summary report: N
LMA LARYNGEAL MASK
MDR report key: 3131258
·
Received May 23, 2013
Report
- Report Number
- 9681900-2013-00009
- Event Type
- Malfunction
- Date Received
- May 23, 2013
- Date of Event
- April 23, 2013
- Report Date
- April 29, 2013
- Manufacturer
- TELEFLEX MEDICAL ASIA PTE LTD
- Product Code
- CAE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CATALOG NUMBER AND LOT NUMBER ARE UNK.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS THAT THE APERTURE BARS WERE CUT/REMOVED PRIOR TO INSERTION IN THE PT. DURING A PROCEDURE (BRONCHOSCOPY), THE CRNA NOTICED A FOREIGN BODY WHICH APPEARED TO BE PLASTIC. THE ASSUMPTION, BY THE USER FACILITY, WAS THAT IT CAME FROM THE LMA. THE FOREIGN BODY WAS NOT RETRIEVED AND THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230271 | LMA LARYNGEAL MASK | LARYNGEAL MASK AIRWAY | CAE | TELEFLEX MEDICAL ASIA PTE LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |