Brand Name | A'SCOPE, A'CLAVE, HD, 4MM X 30° |
Type of Device | ACCESSORIES,ARTHROSCOPIC |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
150 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
150 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
jim
gonzales
|
150 minuteman road |
andover, MA 01810
|
5123585706
|
|
MDR Report Key | 5979011 |
MDR Text Key | 55686248 |
Report Number | 3003604053-2016-00087 |
Device Sequence Number | 1 |
Product Code |
NBH
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
02/28/2014 |
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 Catalogue Number | 72202087 |
Device Lot Number | BBJ846740 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/28/2014
|
Initial Date FDA Received | 09/27/2016 |
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 |
|
|