Brand Name | SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE |
Type of Device | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
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
|
|
MDR Report Key | 7151631 |
MDR Text Key | 96059784 |
Report Number | 1643264-2017-01860 |
Device Sequence Number | 1 |
Product Code |
HWE
|
UDI-Device Identifier | 03596010653703 |
UDI-Public | (01)03596010653703 |
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 |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/22/2018 |
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 | 72200872S |
Device Catalogue Number | 72200872S |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/17/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/27/2017 |
Initial Date FDA Received | 12/28/2017 |
Supplement Dates Manufacturer Received | 02/19/2018
|
Supplement Dates FDA Received | 02/22/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|