MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-12-02 for ANKLE BRACE manufactured by Djo, Llc.
[16586164]
Claimant claims in the complaint that the patient sustained injuries and that the injuries resulted from wear the product. There is no additional information in the complaint about the personal injury. The company has been unable to inspect the device. Because the matter is potentially in litigation, it has been turned over to outside counsel for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00130 |
| MDR Report Key | 2362926 |
| Report Source | 99 |
| Date Received | 2011-12-02 |
| Date of Report | 2011-12-01 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2011-11-04 |
| Date Added to Maude | 2011-12-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANKLE BRACE |
| Generic Name | RIGID BRACING |
| Product Code | ITW |
| Date Received | 2011-12-02 |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-02 |