Brand Name | THE BLAZER |
Type of Device | ROLLATOR |
Manufacturer (Section D) |
FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO LTD |
youhe industry area, luoxing |
danzao town, nanhai district |
foshan city, guangdong 52821 6 |
CH 528216 |
|
MDR Report Key | 16643641 |
MDR Text Key | 312307103 |
Report Number | 1056127-2023-00006 |
Device Sequence Number | 1 |
Product Code |
ITJ
|
UDI-Device Identifier | 00754756360764 |
UDI-Public | 754756360764 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/30/2023,03/23/2023 |
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 Model Number | HFK-9232 |
Device Catalogue Number | W1631BK |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/30/2023 |
Distributor Facility Aware Date | 03/23/2023 |
Device Age | 8 MO |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 03/29/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/30/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 55 YR |
Patient Sex | Male |
Patient Weight | 88 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|