Brand Name | DYONICS 4.0MM ELITE STONECUTTER BURR |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
MDR Report Key | 8709609 |
MDR Text Key | 148644787 |
Report Number | 1219602-2019-00721 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010578068 |
UDI-Public | 03596010578068 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
08/16/2019 |
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 Expiration Date | 12/09/2023 |
Device Catalogue Number | 72200728 |
Device Lot Number | 50774845 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2019 |
Initial Date Manufacturer Received |
05/28/2019 |
Initial Date FDA Received | 06/18/2019 |
Supplement Dates Manufacturer Received | 05/28/2019 07/15/2019 08/13/2019
|
Supplement Dates FDA Received | 06/18/2019 07/16/2019 08/16/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |