Brand Name | STRYKEFLOW 2 |
Type of Device | APPARATUS, SUCTION, OPERATING-ROOM |
Manufacturer (Section D) |
STRYKER CORPORATION |
5900 optical ct |
san jose CA 95138 |
|
MDR Report Key | 7372875 |
MDR Text Key | 103551728 |
Report Number | 7372875 |
Device Sequence Number | 1 |
Product Code |
GCX
|
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 |
03/07/2018,03/19/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/27/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 12/20/2019 |
Device Catalogue Number | 250-070-520 |
Device Lot Number | 17354FG2 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/22/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/07/2018 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/07/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 69 YR |
Patient Weight | 53 |
|
|