Brand Name | SWANN MORTON |
Type of Device | SINGLE USE SCALPEL BLADE |
Manufacturer (Section D) |
SWANN MORTON, LTD |
owlerton green |
sheffield, |
UK |
|
Manufacturer (Section G) |
SWANN MORTON, LTD |
owlerton green |
|
sheffield, |
UK
|
|
Manufacturer Contact |
kevin
walls
|
33 golden eagle lane |
littleton, CO 80127
|
7209625412
|
|
MDR Report Key | 6883403 |
MDR Text Key | 87872944 |
Report Number | 9611194-2017-00005 |
Device Sequence Number | 1 |
Product Code |
GES
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/21/2017 |
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 | 0291 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/11/2017 |
Initial Date FDA Received | 09/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|