Brand Name | SCORPION-MULTIFIRE NEEDLE |
Type of Device | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 16086924 |
MDR Text Key | 308505087 |
Report Number | 1220246-2023-06017 |
Device Sequence Number | 1 |
Product Code |
MDM
|
UDI-Device Identifier | 00888867015951 |
UDI-Public | 00888867015951 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
01/03/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/03/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | SCORPION-MULTIFIRE NEEDLE |
Device Catalogue Number | AR-13995N |
Device Lot Number | 14956914 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/14/2022 |
Date Device Manufactured | 05/04/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|