MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-08-23 for AIRCAST WALKER manufactured by Djo Global.
[2245939]
It was reported that a patient developed a thrombosis while wearing an aircast walker. Unconfirmed report. No patient or product data provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00095 |
| MDR Report Key | 2226946 |
| Report Source | 99 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-07-28 |
| Date Added to Maude | 2011-09-02 |
| 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 ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST WALKER |
| Generic Name | WALKER BOOT |
| Product Code | IPG |
| Date Received | 2011-08-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-23 |