Brand Name | DRIVE |
Type of Device | POWER MOBILITY |
Manufacturer (Section D) |
WUS TECH (VIETNAM) CO., LTD. |
no. 31-33, road 6th, vsip2 |
hoa phu ward, |
thu dau mot, binh duong |
VM |
|
Manufacturer Contact |
khoa
ben dao
|
no. 31-33, road 6th, vsip2 |
hoa phu ward, |
thu dau mot, binh duong
|
VM
|
|
MDR Report Key | 10048533 |
MDR Text Key | 216163889 |
Report Number | 3007963811-2019-00002 |
Device Sequence Number | 1 |
Product Code |
ITI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/12/2019 |
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 |
Lay User/Patient
|
Device Model Number | SFSCOUT4 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/12/2019 |
Distributor Facility Aware Date | 06/18/2019 |
Device Age | 2 MO |
Event Location |
Other
|
Date Report to Manufacturer | 07/15/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/12/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|