Brand Name | FULL RADIUS BLADE 3.5MM DISP |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes blvd. |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes blvd. |
|
mansfield MA 02048 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 12894113 |
MDR Text Key | 281411248 |
Report Number | 1219602-2021-02609 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010251336 |
UDI-Public | 03596010251336 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/03/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 7205305 |
Device Catalogue Number | 7205305 |
Device Lot Number | 50925533 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/08/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/08/2021 |
Initial Date FDA Received | 11/30/2021 |
Supplement Dates Manufacturer Received | 03/02/2022
|
Supplement Dates FDA Received | 03/03/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/07/2021 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|