Brand Name | CAREX |
Type of Device | STEEL ROLLING WALKER |
Manufacturer (Section D) |
AID-PRO HEALTHCARE CO., LTD. |
no. 58 yu long 3 road |
dong sheng town |
zhong shan city, |
CH |
|
MDR Report Key | 6985575 |
MDR Text Key | 90510402 |
Report Number | 3012316249-2017-00127 |
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 |
Attorney
|
Type of Report
| Initial,Followup |
Report Date |
08/17/2018,08/17/2017 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | FGA22100 0000 |
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 | 08/17/2018 |
Distributor Facility Aware Date | 08/17/2018 |
Date Report to Manufacturer | 08/17/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/27/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/17/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|