MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-07-31 for ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM 40-01148 manufactured by Solta Medical.
[6636112]
It was reported that the patient was treated on the face and one to two hours post treatment a burn appeared on the left cheek. The highest power level used was 3. There were no system errors. The patient was seen by a physician at the treating clinic several days after the burn appeared. The burn is approximately 1. 5 cm by 1 cm. The patient did not undergo significant sun exposure prior to or during the course of treatment to the physician''s knowledge - the patient is relatively careful with sun exposure. The burn was classified as a second degree burn with crusting. The patient was prescribed duoderm dressing for moisture retention. The physician suspects there may be post-inflammatory hyperpigmentation but there may not be a scar.
Patient Sequence No: 1, Text Type: D, B5
[14308564]
Investigation of this event is in progress. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[33237545]
The device has not been returned to solta medical, therefore, a product evaluation has not been conducted. The user facility has confirmed that the device is functioning as designed without any technical issues. The device history records were reviewed and there were no non-conformities or anomalies found related to the reported event. The reported adverse event is a known procedure complication of isolaz treatment. Blisters are an anticipated side-effect of isolaz treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002954746-2015-00010 |
| MDR Report Key | 4958352 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-18 |
| Date Mfgr Received | 2015-09-21 |
| Device Manufacturer Date | 2007-08-03 |
| Date Added to Maude | 2015-07-31 |
| 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 | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | SOLTA MEDICAL |
| Manufacturer Street | 25881 INDUSTRIAL BLVD |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM |
| Generic Name | POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT |
| Product Code | ONF |
| Date Received | 2015-07-31 |
| Catalog Number | 40-01148 |
| ID Number | NI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | HAYWARD CA 94545 US 94545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-31 |