Brand Name | ABRADER, 3.5, MAG-MINI, DISP. BLADE |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 7787277 |
MDR Text Key | 117257043 |
Report Number | 1219602-2018-01075 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010621641 |
UDI-Public | (01)03596010621641(17)191114(10)50631209 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/21/2018 |
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 Expiration Date | 11/14/2019 |
Device Model Number | 72201519 |
Device Catalogue Number | 72201519 |
Device Lot Number | 50631209 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2018 |
Initial Date Manufacturer Received |
07/18/2018 |
Initial Date FDA Received | 08/15/2018 |
Supplement Dates Manufacturer Received | 08/20/2018
|
Supplement Dates FDA Received | 08/21/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/14/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |