Brand Name | N/A |
Type of Device | SCALPEL, ULTRASONIC, REPROCESSED |
Manufacturer (Section D) |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
1810 west drake dr |
tempe AZ 85283 |
|
MDR Report Key | 7244558 |
MDR Text Key | 99134256 |
Report Number | 7244558 |
Device Sequence Number | 1 |
Product Code |
NLQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/11/2018,01/19/2018 |
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 |
Physician
|
Device Catalogue Number | HARH36 |
Device Lot Number | 7071133 AND 7098477 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/11/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/11/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/06/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO |
Patient Age | 60 YR |
|
|