Brand Name | AUTOLOGOUS TISSUE COLLECTOR |
Type of Device | ACCESSORIES, ARTHROSCOPIC |
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 | 13472059 |
MDR Text Key | 285218086 |
Report Number | 1220246-2022-04426 |
Device Sequence Number | 1 |
Product Code |
NBH
|
UDI-Device Identifier | 00888867306189 |
UDI-Public | 00888867306189 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/07/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | AUTOLOGOUS TISSUE COLLECTOR |
Device Catalogue Number | ABS-1050 |
Device Lot Number | 1187113713 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/19/2022
|
Initial Date FDA Received | 02/07/2022 |
Date Device Manufactured | 07/01/2021 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|