Brand Name | SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM |
Type of Device | ARTHROSCOPE |
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
|
7000 w. william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 6819050 |
MDR Text Key | 83741108 |
Report Number | 3003604053-2017-00083 |
Device Sequence Number | 1 |
Product Code |
HRX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K962075 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
08/24/2017 |
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 Catalogue Number | 72202087S |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/07/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/03/2017 |
Initial Date FDA Received | 08/24/2017 |
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 |
|
|