MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-25 for STARSCANNER * manufactured by Orthoamerica.
[476496]
The starscanner was given 510k clearance. It was deemed to be similar to vorum canfit-plus yeti 3d foot scanner. Because it was "similar" the fda didn't do any clinical trials on the starscanner. The yeti is designed to make orthotics for feet. The starscanner is used to scan an infant's head in order ot make a cranial orthosis, product code mva with the fda. You need to take into consideration an infant will move his head during the scanning process. This can lead to an incorrect fitting orthosis thus deforming the child's head even further. This happened often. What is even more concerning is that on the bottom of the yeti's brochure, it has a warning about not looking into the laser because your eyes can be damaged. Yet, they are scanning babies' heads. Please stop this immediately. Rptr feels not only could they be deforming babies even more they can cause vision problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038142 |
| MDR Report Key | 687550 |
| Date Received | 2006-02-25 |
| Date of Report | 2006-02-25 |
| Date Added to Maude | 2006-03-17 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STARSCANNER |
| Generic Name | * |
| Product Code | MVA |
| Date Received | 2006-02-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676757 |
| Manufacturer | ORTHOAMERICA |
| Manufacturer Address | 505 31ST ST NEWPORT BEACH CA 92663 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2006-02-25 |