MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-08-25 for MULTILIGHT GA2392000 * manufactured by *.
[532016]
End user reported that three patients had experienced second degree burns following ipl treatment. Patient one, treated on ipl. Treatment for rosacea/facial telangiectasis, this appeared to be a very normal treatment", customer concerned the patient will scar; looks like outline of part of the crystal, light blue, there are about 3 of these on the left side of the face. Patient applied neosporin (otc) at home and reported the incident about one month later. Staff tested the system on herself and also received second degree burns. The patients reported the incidents too late to be considred for medical intervention; the staff member applied silvadene and believes she may have the same light blue scars as patient one. Customer requested service. Customer was advised to suspend use of the device pending evaluation by lumenis. Customer was also advised to refrain from further testing of the device on staff.
Patient Sequence No: 1, Text Type: D, B5
[7796271]
The customer had inserted the crystal (filter) too far into the treatment head and this had fractured the internal filter of the ipl head. This appears to be the root cause of the incident. The customer had another treatment head and the ge inserted the light guides into the other head, tested and verified head output was in specification. Ge instructed customer on proper management of the treatment head.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2914019-2006-00073 |
| MDR Report Key | 754366 |
| Report Source | 00 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-08-24 |
| Date of Event | 2006-07-27 |
| Date Mfgr Received | 2006-07-27 |
| Date Added to Maude | 2006-08-28 |
| 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 | JANIS ARRIGON |
| Manufacturer Street | 2400 CONDEVSA ST |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643401 |
| Manufacturer G1 | LUMENIS ISRAEL |
| Manufacturer Street | PO BOX 240 YOKNEAM |
| Manufacturer City | * 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTILIGHT |
| Generic Name | COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASE( |
| Product Code | FTC |
| Date Received | 2006-08-25 |
| Model Number | GA2392000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 742186 |
| Manufacturer | * |
| Manufacturer Address | 13 HAYELZIRA STREET * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-25 |