Brand Name | ENDOSCOPIC CANN DRILL BIT 7MM |
Type of Device | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
MDR Report Key | 8554845 |
MDR Text Key | 143410463 |
Report Number | 1219602-2019-00471 |
Device Sequence Number | 1 |
Product Code |
HWE
|
UDI-Device Identifier | 03596010091611 |
UDI-Public | 03596010091611 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Type of Report
| Initial,Followup |
Report Date |
06/18/2019 |
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 | 013660 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/28/2019 |
Initial Date FDA Received | 04/26/2019 |
Supplement Dates Manufacturer Received | 06/14/2019
|
Supplement Dates FDA Received | 06/18/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|