Brand Name | MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL |
Type of Device | W, 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 west william cannon drive |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 7714322 |
MDR Text Key | 114953354 |
Report Number | 1643264-2018-00542 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010565105 |
UDI-Public | (01)03596010565105 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/06/2018 |
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 |
Health Professional
|
Device Model Number | 72200616S |
Device Catalogue Number | 72200616 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/27/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/16/2018 |
Initial Date FDA Received | 07/24/2018 |
Supplement Dates Manufacturer Received | 08/03/2018
|
Supplement Dates FDA Received | 08/06/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|