Brand Name | MOTOR DRIVE UNIT HAND CNTRL PWRMX EL |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
oklahoma city OK 73107 6512 |
|
MDR Report Key | 8581798 |
MDR Text Key | 144125132 |
Report Number | 1643264-2019-00312 |
Device Sequence Number | 1 |
Product Code |
HAB
|
UDI-Device Identifier | 03596010555472 |
UDI-Public | 03596010555472 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
06/10/2019 |
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 | 72200616 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/08/2019 |
Initial Date Manufacturer Received |
04/11/2019 |
Initial Date FDA Received | 05/06/2019 |
Supplement Dates Manufacturer Received | 06/10/2019
|
Supplement Dates FDA Received | 06/10/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|