Brand Name | LMA SUPREME SIZE 3 |
Type of Device | LMA SUPREME |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
THE LARYNGEAL MASK COMPANY |
6 battery road #07-02 |
|
singapore 04990 9 |
SN
049909
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9193614124
|
|
MDR Report Key | 15192796 |
MDR Text Key | 304886185 |
Report Number | 9681900-2022-00027 |
Device Sequence Number | 1 |
Product Code |
CAE
|
UDI-Device Identifier | 15060112318082 |
UDI-Public | 15060112318082 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/19/2022 |
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 Expiration Date | 10/28/2022 |
Device Model Number | IPN922810 |
Device Catalogue Number | 175030 |
Device Lot Number | PMCR6R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/19/2022
|
Initial Date FDA Received | 08/09/2022 |
Supplement Dates Manufacturer Received | 08/26/2022
|
Supplement Dates FDA Received | 08/26/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | N/A.; N/A. |
|
|