Brand Name | DR. COMFORT RELAX CHOCOLATE 10 WIDE |
Type of Device | ORTHOSIS, CORRECTIVE SHOE |
Manufacturer (Section D) |
DR. COMFORT, A DJO, LLC COMPANY |
10300 enterprise dr. |
mequon, wi 53092 |
|
Manufacturer (Section G) |
DR. COMFORT, A DJO, LLC COMPANY |
10300 enterprise dr. |
|
mequon, wi 53092 |
|
Manufacturer Contact |
brian
becker
|
2900 lake vista drive |
lewisville, TX 75067
|
|
MDR Report Key | 8682849 |
MDR Text Key | 147462396 |
Report Number | 3008579854-2019-00006 |
Device Sequence Number | 1 |
Product Code |
KNP
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
06/07/2019 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 5220-W-10.0 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
05/20/2019 |
Initial Date FDA Received | 06/10/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|