Brand Name | ACROMIONIZER,4.0 EP-1,DSPL BL |
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 | 7681989 |
MDR Text Key | 113785080 |
Report Number | 1219602-2018-00894 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (Y/N) | N |
Reporter Country Code | IT |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
DISTRIBUTOR,FOREIGN,HEALTH PR |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
08/17/2018 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 07/12/2018 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | 7205326 |
Device Catalogue Number | 7205326 |
Device LOT Number | 50715057 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/14/2018 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 02/15/2018 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient TREATMENT DATA |
Date Received: 07/12/2018 Patient Sequence Number: 1 |
|
|