MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for DIGIT WIDGET DWD-232 manufactured by Hand Biomechanics Lab, Inc..
| Report Number | 2919128-2020-00004 |
| MDR Report Key | 9883951 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2020-01-07 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTIN DEQUINE |
| Manufacturer Street | 77 SCRIPPS DRIVE, SUITE 104 |
| Manufacturer City | SACRAMENTO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 9235073 |
| Manufacturer G1 | HAND BIOMECHANICS LAB, INC. |
| Manufacturer Street | 77 SCRIPPS DRIVE, SUITE 104 |
| Manufacturer City | SACRAMENTO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGIT WIDGET |
| Generic Name | DIGIT WIDGET |
| Product Code | JDW |
| Date Received | 2020-03-26 |
| Model Number | DWD-232 |
| Catalog Number | DWD-232 |
| Lot Number | DWD-119-120A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAND BIOMECHANICS LAB, INC. |
| Manufacturer Address | 77 SCRIPPS DRIVE, SUITE 104 SACRAMENTO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |