Brand Name | PRECISION THIN BLADE |
Type of Device | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
Manufacturer (Section D) |
STRYKER CORPORATION |
3800 e. centre ave |
portage MI 49002 |
|
MDR Report Key | 15868400 |
MDR Text Key | 304333654 |
Report Number | 15868400 |
Device Sequence Number | 1 |
Product Code |
GFA
|
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 |
11/17/2022,08/18/2022 |
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 | 2296-003-125 |
Device Lot Number | 21291037 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/17/2022 |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 11/28/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/28/2022 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 9125 DA |
Patient Sex | Female |
|
|