Brand Name | DRIVE |
Type of Device | ROLLATOR |
Manufacturer (Section D) |
HL CORP. (SHENZHEN) |
the 3rd industrial park |
bitou village, song gang town |
baoan district, shenzhen, guangdong 51810 5 |
CH 518105 |
|
MDR Report Key | 7039335 |
MDR Text Key | 92304057 |
Report Number | 2438477-2017-00087 |
Device Sequence Number | 1 |
Product Code |
ITJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/16/2017,10/27/2017 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 10215RD-1 |
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 | 11/16/2017 |
Distributor Facility Aware Date | 10/27/2017 |
Device Age | 6 MO |
Event Location |
Other
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/16/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 45 YR |
Patient Weight | 238 |
|
|