MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-05 for ULTRALITE FULL BODY V4824ANB NA manufactured by Ultralite Ent., Inc..
[18968446]
Pt. Received treatment and small blister occurred. The reporter states unit was cleaned by sarco co. 02-24-06. No light bulbs changed. He states after cleaning unit did not work right. The reporter states technician will be retrained. Pt. Has completely healed. Pt was treated with topical inocin and aloe to pain. No hosp. Required.
Patient Sequence No: 1, Text Type: D, B5
[18893051]
A pt received treatment and it caused painful sunburn. Pt was treated with indocin and aloe topically. No hospitalization required. 03-10-06 the reporter stated technician would be retrained. Unit was cleaned by sarco co. 2-24-06 (unkt used for 3 patients on 2-27-06 and this one patient on 3-6-06.
Patient Sequence No: 2, Text Type: D, B5
[19003196]
Pt. Received treatment and resulted in painful sunburn. Pt treated with indocin and aloe. No hosp. Required. Pt has resumed treatments all is normal.
Patient Sequence No: 3, Text Type: D, B5
[19004085]
Pt. Received treatment and resulted in painful sunburn. Pt was treated with indocin and aloe. No hosp. Required. Pt has resumed treatments and all is normal.
Patient Sequence No: 4, Text Type: D, B5
| Report Number | 1045025-2006-00001 |
| MDR Report Key | 698111 |
| Report Source | 05 |
| Date Received | 2006-04-05 |
| Date of Report | 2006-03-10 |
| Date of Event | 2006-02-27 |
| Date Mfgr Received | 2006-03-10 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-04-12 |
| 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 | 3 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE FULL BODY |
| Generic Name | ULTRALITE DERMATOLOGICAL LIGHT |
| Product Code | KGL |
| Date Received | 2006-04-05 |
| Model Number | V4824ANB |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2007-04-25 |
| 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 | 687200 |
| Manufacturer | ULTRALITE ENT., INC. |
| Manufacturer Address | 390 FARMER CT. LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE FULL BODY |
| Baseline Generic Name | ULTRALITE DERMATOLOGICAL LIGHT |
| Baseline Model No | V4824ANB |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-05 |
| 2 | 0 | 1. Other | 2006-04-05 |
| 3 | 0 | 1. Other | 2006-04-05 |
| 4 | 0 | 2006-04-05 |