Brand Name | MICROAIRE |
Type of Device | BURR, ORTHOPEDIC |
Manufacturer (Section D) |
MICROAIRE SURGICAL INSTRUMENTS LLC |
3590 grand forks blvd |
charlottesville VA 22911 |
|
MDR Report Key | 9354386 |
MDR Text Key | 167389401 |
Report Number | 9354386 |
Device Sequence Number | 1 |
Product Code |
HTT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
10/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/21/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ZB-214 |
Device Lot Number | 1218334412 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/30/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/21/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 20805 DA |
Patient Weight | 86 |
|
|