FDA Adverse Event
Injury
Summary report: N
DONJOY
MDR report key: 6741593
·
Received July 25, 2017
Report
- Report Number
- 9616086-2017-00012
- Event Type
- Injury
- Date Received
- July 25, 2017
- Date of Event
- June 22, 2017
- Report Date
- July 25, 2017
- Manufacturer
- DJO, LLC
- Product Code
- ITQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLAINT RECEIVED THAT ALLEGES "AS HE STARTED TO WALK HE TOOK FOUR STEPS AND THE CAPS CAUGHT UP AND LOCKED UP AND HINGES ALSO LOCKED UP ON HIM AND FELL. HE WAS ALSO HELPING A FRIEND PICK UP A BEER KEG AND HIS FRIEND SLOWED DOWN HE TOOK A STEP AND AGAIN THEY LOCKED HE FELL DOWN AND HIT HIS HEAD THE BEER KEG LANDED ON HIS FINGER HE WAS APPLIED WITH STITCHES .HE IS ALSO LIMITED ON CARING STUFF". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522745 | DONJOY | OA NANO, LATERAL, LT, M | ITQ | DJO, LLC | 11-1217-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 11-1216-3, OA NANO, LATERAL, RT, M |