Brand Name | BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK |
Type of Device | BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK |
Manufacturer (Section D) |
GYRUS ACMI, INC |
136 turnpike road |
southborough MA 01772 |
|
MDR Report Key | 10734003 |
MDR Text Key | 213054009 |
Report Number | 1037007-2020-00072 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT-EQJ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
12/28/2020 |
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 |
Health Professional
|
Device Model Number | BUR3070DB |
Device Lot Number | LOTCA845666 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/29/2020 |
Initial Date FDA Received | 10/26/2020 |
Supplement Dates Manufacturer Received | 11/30/2020
|
Supplement Dates FDA Received | 12/28/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|