MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for L300 GO manufactured by Bioness.
[92869869]
Brace burned skin. Causing pain and difficulty walking with already having difficulties hence the need for the brace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073521 |
| MDR Report Key | 7052417 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-18 |
| Date of Event | 2017-11-15 |
| Date Added to Maude | 2017-11-22 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | L300 GO |
| Generic Name | STIMULATOR, NEUROMUSCULAR, EXTERNAL |
| Product Code | GZI |
| Date Received | 2017-11-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONESS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-22 |