MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-31 for BIOMEDIX VDL * manufactured by Biomedix.
[570787]
Complainant will send e-mail with specifics. Multiple problems with device. Has been sent back multiple times without resolution. Loaner machine did not work properly either. Erratic readings and serious inaccuracies in readings. Ex: machine will say blockage in left leg when blockage is actually in right leg. Luckily experienced vascular tech noticed inaccuracies before surgeries. Have heard others in the field with same complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4004280 |
| MDR Report Key | 811227 |
| Date Received | 2007-01-31 |
| Date of Report | 2007-01-18 |
| Date Added to Maude | 2007-02-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMEDIX |
| Generic Name | PULSE VOLUME RECORDER MODEL VDL |
| Product Code | JOM |
| Date Received | 2007-01-31 |
| Model Number | VDL |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 798711 |
| Manufacturer | BIOMEDIX |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-31 |