FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 19986763
·
Received August 14, 2024
Report
- Report Number
- 2919128-2024-00004
- Event Type
- Injury
- Date Received
- August 14, 2024
- Date of Event
- July 1, 2024
- Report Date
- July 31, 2024
- 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
- 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 CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 0
ON JULY 30, THE PATIENT'S WIFE CONTACTED TN TO SEEK MORE CUFFS FOR CLEANING. SINCE HE WAS LOCAL, THE PATIENT WENT TO THE HBL OFFICE TO PICK UP SUPPLIES FROM TN. WHILE AT THE OFFICE, THE PATIENT SAID THAT HIS FINGER IS A BIT SENSITIVE DUE TO AN INFECTION, AND THAT HE IS TAKING ANTIBIOTICS. THE PATIENT MENTIONED THAT HE IS UNAWARE OF WHAT CAUSED THE INFECTION, BUT HE IS REALLY PLEASED WITH THE OUTCOMES OF THIS TREATMENT THUS FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1152882 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC | DWD-232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |