FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 19911631
·
Received August 5, 2024
Report
- Report Number
- 2919128-2024-00003
- Event Type
- Injury
- Date Received
- August 5, 2024
- Date of Event
- March 11, 2024
- Report Date
- July 18, 2024
- Manufacturer
- HAND BIOMECHANICS LAB, INC
- Product Code
- JDW
- PMA / PMN Number
- K992970
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADATION DOSE LOT OR DEVICE LOT WAS NOTED. LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 0
ON (B)(6) 2024, TN EMAILED DR. (B)(6) TO INQUIRE ABOUT THEIR FIRST PATIENT'S PROGRESS SINCE (B)(6). DR. (B)(6) INDICATED THAT THE PATIENT'S NONCOMPLIANCE ON ONE OF THE FINGERS CAUSED AN INFECTION. THE OTHER FINGER IS JUST SLIGHTLY BETTER DUE TO COMPLIANCE. ONE FINGER WAS REMOVED AT THE PATIENT'S REQUEST. DR. (B)(6) INDICATED THAT THE CAUSE OF THE INFECTION UNCLEAR. EVEN AFTER THE DW WAS REMOVED, THE INFECTION CONTINUED DESPITE ORAL ANTIBIOTIC TREATMENT. DR. REVEALED THAT THE PATIENT HAD SKIPPED MANY VISITS WITH BOTH THEM AND THE THERAPISTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2274210 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC | DWD-232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Prefer Not To Disclose | Required Intervention |