FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 20239690
·
Received September 17, 2024
Report
- Report Number
- 2919128-2024-00005
- Event Type
- Injury
- Date Received
- September 17, 2024
- Date of Event
- July 25, 2024
- Report Date
- September 6, 2024
- Manufacturer
- HAND BIOMECHANICS LAB, INC
- Product Code
- JDW
- PMA / PMN Number
- K992970
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. LABELING INCLUDED REGARDING PIN SITE CARE.
Description of Event or Problem · 0
ON (B)(6) 2024, THE PATIENT CALLED HBL TO REQUEST BANDS. TN INQUIRED ABOUT THE PATIENT'S TREATMENT STATUS, AND THE PATIENT RESPONDED THAT THEY HAD BEEN TAKING ANTIBIOTICS FOR 7 DAYS TO TREAT AN INFECTION. THE PATIENT MENTIONED TO HER SURGEON THAT HER FINGER WAS RED AND SWOLLEN. THE DOCTOR SUGGESTED THE PATIENT TO LIFT THE PIN BLOCK FOR MORE EFFECTIVE CLEANING WITH 50% H2O AND 50% SALINE. THE DOCTOR WILL LEAVE THE DEVICE ON FOR ANOTHER SIX WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1901987 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC | DWD-232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |