FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 11088220
·
Received December 29, 2020
Report
- Report Number
- 2919128-2020-00009
- Event Type
- Injury
- Date Received
- December 29, 2020
- Date of Event
- December 7, 2020
- Report Date
- December 29, 2020
- Manufacturer
- HAND BIOMECHANICS LAB, INC.
- Product Code
- JDW
- UDI-DI
- 00861994000212
- PMA / PMN Number
- K992970
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 1
PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. PATIENT REPORTED 13 DAYS POST OPERATIVE THAT HE WAS GIVEN PRESCRIPTION ANTIBIOTICS FOR A PIN SITE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555416 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC. | DWD-232 | DWD-118-033B | 00861994000212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |