Brand Name | 4.0MM ROUND TRDO BURR PLUS 5PK |
Type of Device | ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE |
Manufacturer (Section D) |
DEPUY MITEK LLC US |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer Contact |
kara
ditty-bovard
|
325 paramount drive |
raynham, MA 02767
|
6103142063
|
|
MDR Report Key | 13482977 |
MDR Text Key | 288029384 |
Report Number | 1221934-2022-00431 |
Device Sequence Number | 1 |
Product Code |
HRX
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K131191 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 02/08/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 283479 |
Device Catalogue Number | 283479 |
Device Lot Number | M1911063 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 03/28/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/27/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|