Brand Name | INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ |
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 | 8542065 |
MDR Text Key | 142896362 |
Report Number | 1219602-2019-00459 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010555694 |
UDI-Public | 03596010555694 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | E527289 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/06/2019 |
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 | 72200095 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/03/2019 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/17/2019 |
Initial Date FDA Received | 04/23/2019 |
Supplement Dates Manufacturer Received | 06/05/2019
|
Supplement Dates FDA Received | 06/06/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|