MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-02 for WALKAIDE manufactured by Innovative Neurotronics.
[932225]
This patient uses the walkaide device from innovative neurotronics which is a device that uses skin surface electrodes to treat drop foot. Patient's father e-mailed on 08/27/2008 stating that the patient had developed sores on her leg at the electrode sites, which took approximately one month to heal. Patient has not been wearing the walkaide since the sores developed. I have not seen the patient since the sores developed. We are currently trying to schedule for follow up. Dates of use: 2008. Diagnosis or reason for use: drop foot, traumatic brain injury. Event abated after use stopped or dose reduced: yes. The walkaide was delivered to the patient in 2008. I do not know when the device was discontinued, however, the father stated in his e-mail that the patient stopped using the device about one month prior to sending the 08/27/2008 e-mail notifying me that the patient had developed sores.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008165 |
| MDR Report Key | 1146184 |
| Date Received | 2008-09-02 |
| Date of Report | 2008-09-02 |
| Date of Event | 2008-07-28 |
| Date Added to Maude | 2008-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAIDE |
| Generic Name | WALKAIDE |
| Product Code | GZI |
| Date Received | 2008-09-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1166404 |
| Manufacturer | INNOVATIVE NEUROTRONICS |
| Manufacturer Address | BETHESDA MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-02 |