FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 8200532
·
Received December 27, 2018
Report
- Report Number
- 2919128-2018-00032
- Event Type
- Injury
- Date Received
- December 27, 2018
- Report Date
- December 26, 2018
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALIZED 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 SYSTEM. PHYSICIAN REPORTED PATIENT WORE DEVICE FOR 2 WEEKS. DEVELOPED 'INFECTION THEN PINS PULLED OUT.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1039135 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC. | DWD-232 | DWD-112-097B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |