MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-12 for ULTRALITE H/F1200D * manufactured by Ultralite Enterprises.
[300902]
Add'l info rec'd on 07/29/2003: ultralite was not informed of any incident regarding a "machine spark" from facility. A call has been placed to the facility regarding the unit in question. Model number h/f1200d. Facility also stated machine is working fine, was checked out by biomedical employees at the facility and there was no consequence or impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
[306129]
Machine sparked following patient treatment. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028710 |
| MDR Report Key | 466239 |
| Date Received | 2003-06-12 |
| Date of Report | 2003-06-06 |
| Date of Event | 2003-05-08 |
| Date Added to Maude | 2003-06-19 |
| 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 | ULTRALITE |
| Generic Name | UVA HANDY FOOT MACHINE |
| Product Code | KGL |
| Date Received | 2003-06-12 |
| Model Number | H/F1200D |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 455182 |
| Manufacturer | ULTRALITE ENTERPRISES |
| Manufacturer Address | 390 FARMER COURT LAWRENCEVILLE GA 30045 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-06-12 |