FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 14593686
·
Received June 3, 2022
Report
- Report Number
- 2919128-2022-00003
- Event Type
- Injury
- Date Received
- June 3, 2022
- Report Date
- June 3, 2022
- Manufacturer
- HAND BIOMECHANICS LAB, INC.
- Product Code
- JDW
- PMA / PMN Number
- K992970
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADIATION DOSE LOTS OR DEVICE LOTS WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 0
PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PATIENT REPORTED SHE WAS TREATED WITH ANTIBIOTICS FOR A PIN SITE INFECTION AND THE INFECTION CLEARED. PATIENT HISTORY INCLUDES LUPUS AND LATEX ALLERGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1586423 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC. | DWD-232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |