Brand Name | MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
oklahoma city OK 73107 6512 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
|
oklahoma city OK 73107 6512 |
|
Manufacturer Contact |
jim
gonzales
|
7000 w. william cannon |
austin, TX 78735
|
|
MDR Report Key | 7014213 |
MDR Text Key | 92660591 |
Report Number | 1643264-2017-01685 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Type of Report
| Initial |
Report Date |
11/09/2017 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 11/09/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | 72200616 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 02/02/2015 |
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
|
|