MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-12 for RELIEF BAND * manufactured by Woodside Biomedical.
[145862]
Raised red skin irritation from the metal on the wristband.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017922 |
| MDR Report Key | 258618 |
| Date Received | 2000-01-12 |
| Date of Report | 2000-01-12 |
| Date of Event | 1999-12-23 |
| Date Added to Maude | 2000-01-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEF BAND |
| Generic Name | ELECTRICAL STIMULATION WRISTBAND |
| Product Code | BWK |
| Date Received | 2000-01-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | B9911A3 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 250447 |
| Manufacturer | WOODSIDE BIOMEDICAL |
| Manufacturer Address | 1915 ASTON AVE. SUITE 102 CARLSBAD CA 92008 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-01-12 |