Brand Name | LMA PROSEAL, REU, SIZE 4 |
Type of Device | LARYNGEAL MASK AIRWAY |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
THE LARYNGEAL MASK COMPANY |
6 battery road #07-02 |
|
singapore 04990 9 |
SN
049909
|
|
Manufacturer Contact |
warrenda
peterson
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9193613959
|
|
MDR Report Key | 6184221 |
MDR Text Key | 62688309 |
Report Number | 9681900-2016-00060 |
Device Sequence Number | 1 |
Product Code |
CAE
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/12/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 15140 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/20/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/12/2016
|
Initial Date FDA Received | 12/17/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/07/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|