MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-27 for DONJOY DEFIANCE FP CONV DEFIANCE FP manufactured by Djo, Llc.
[182180616]
Reporter information: unknown. No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[182180617]
It was reported that the patient with a previous anterior cruciate ligament injury "pivoted playing frisbee and tore the meniscus while wearing the brace. " the brace would reportedly "slide a bit during running. " no further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2020-00005 |
| MDR Report Key | 9764685 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-03-02 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT ST. |
| Manufacturer City | VISTA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY DEFIANCE FP |
| Generic Name | JOINT, KNEE, EXTERNAL BRACE |
| Product Code | ITQ |
| Date Received | 2020-02-27 |
| Model Number | CONV DEFIANCE FP |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |