MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2003-10-28 for ULTRALITE HAND/FOOT 1200D NA manufactured by Ultralite Enterprises, Inc..
[331336]
Pt called office 2003 stating they had been burned on both feet by hf1200d. Stated they were in the hosp 2 months. Institution did tell the mfr the unit was serviced by an outside service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2003-00001 |
| MDR Report Key | 492097 |
| Report Source | 00,04 |
| Date Received | 2003-10-28 |
| Date of Report | 2003-10-01 |
| Date of Event | 2003-04-01 |
| Date Mfgr Received | 2003-09-23 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2003-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM MCMILLAN |
| Manufacturer Street | 390 FARMER COURT |
| Manufacturer City | LAWRENCEVILLE GA 30045 |
| Manufacturer Country | US |
| Manufacturer Postal | 30045 |
| Manufacturer Phone | 7709630594 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE HAND/FOOT 1200D |
| Generic Name | ULTRALITE DERMATOLOGICAL LIGHT |
| Product Code | KGL |
| Date Received | 2003-10-28 |
| Model Number | HAND/FOOT 1200D |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 1999-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480797 |
| Manufacturer | ULTRALITE ENTERPRISES, INC. |
| Manufacturer Address | 390 FARMER CT. LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE HAND/FOOT 1200D |
| Baseline Generic Name | ULTRALITE DERMATOLOGICAL LIGHT |
| Baseline Model No | HAND/FOOT 1200D |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-10-28 |