FDA Adverse Event
Injury
Summary report: N
DIGIT WIDGET
MDR report key: 7113230
·
Received December 13, 2017
Report
- Report Number
- 2919128-2017-00005
- Event Type
- Injury
- Date Received
- December 13, 2017
- Date of Event
- November 1, 2016
- Report Date
- December 27, 2018
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF LOT. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 0
IT IS REPORTED PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. PHYSICIAN REPORTED HE PRESCRIBED AN ANTIBIOTIC 10 DAYS POST OPERATIVE.
Additional Manufacturer Narrative · 1
REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF LOT. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.
Description of Event or Problem · 1
IT IS REPORTED PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. PHYSICIAN REPORTED HE PRESCRIBED AN ANTIBIOTIC 10 DAYS POST OPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893173 | DIGIT WIDGET | DIGIT WIDGET | JDW | HAND BIOMECHANICS LAB, INC. | DWD-232 | DWD-115-056B | 00861994000212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |