Brand Name | DIGIT WIDGET |
Type of Device | DIGIT WIDGET |
Manufacturer (Section D) |
HAND BIOMECHANICS LAB, INC. |
77 scripps drive, suite 104 |
sacramento CA 95825 |
|
Manufacturer (Section G) |
HAND BIOMECHANICS LAB, INC. |
77 scripps drive, suite 104 |
|
sacramento CA 95825 |
|
Manufacturer Contact |
dustin
dequine
|
77 scripps drive, suite 104 |
sacramento, CA 95825
|
9169235073
|
|
MDR Report Key | 14547699 |
MDR Text Key | 292974188 |
Report Number | 2919128-2022-00002 |
Device Sequence Number | 1 |
Product Code |
JDW
|
UDI-Device Identifier | 00861994000212 |
UDI-Public | (01)00861994000212(17)310901(10)DWD-121-105A |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K992970 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/31/2022 |
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 |
Health Professional
|
Device Model Number | DWD-232 |
Device Catalogue Number | DWD-232 |
Device Lot Number | DWD-121-105A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/02/2022 |
Initial Date FDA Received | 05/31/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/17/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|