Brand Name | RETRACTOR |
Type of Device | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
7555 innovation way |
mason OH 45040 |
|
MDR Report Key | 8458941 |
MDR Text Key | 140140738 |
Report Number | 8458941 |
Device Sequence Number | 1 |
Product Code |
DWS
|
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,Followup |
Report Date |
03/27/2019 |
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 |
Other
|
Device Model Number | 401-1610 |
Device Catalogue Number | 401-1610 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/27/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/28/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/28/2019 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/05/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 26280 DA |
|
|