MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-06 for HYDRAFACIAL HYDRAFACIAL WAVE 70159-03 manufactured by Edge Systems Llc.
[3499710]
Patient received a facial acid peel (cosmetic treatment) performed by the health professional during the above dates. The suspect products used were cosmetic products containing glycolic acid and salicylic acid; the products were used in conjunction with the hydrafacial wave device. The operator failed to follow instructions for use and precaution to properly cover and protect patient's eyes during facial treatment, causing the acidic fluids to get into patient's eyes and surrounding areas, resulting in reported patient injuries. Those reports include excessive tearing of both eyes; itchiness, swelling, and burning sensation of the eyes and surrounding areas; rash an irritated skin; mild contact dermatitis; lacrimal tear duct stenosis; mild sinusitis with nasal obstruction; mild periorbital cellulitis, etc. Patient also complained about blurry vision, sensitive to light, etc. Patient was caused to use eye drops, facial ointments, warm compresses, medications, and underwent a bilateral lower eyelid punctoplasty. Patient was not hospitalized or confined to bed, but was confined to her home for approximately 30 days intermittently.
Patient Sequence No: 1, Text Type: D, B5
[10761733]
The incident occurred in 2010, but was not brought to edge systems' (manufacturer) attention until recently by the lawsuit between the consumer and the health professional. The attorney provided medical records and details on (b)(6) 2013, so edge systems was able to file a report. The incident was caused by operator neglecting to follow the instructions for use (ifu). It was operator error; no device malfunction or product defects. The suspect cosmetic product(s) used in conjunction with the device contain glycolic acid and salicylic acid at low concentration that are safe to use on human skin surface to remove stratum corneum if the recommend instructions for use are followed properly. The suspect product(s) are not intended to be used on or around the eyes. The ifu provided by edge systems, including use manuals, training dvds, and labels, provide adequate and proper instructions and recommend the use of eye protection for patient during treatment. The ifu also state that if the fluids get into the eyes, rinse with water immediately, and seek medical care if irritation occurs/persists. Edge systems also provided training to the health professional at time of device purchase, educating operators the proper treatment protocols and procedures. In addition, all the lots of suspect product(s) that could possibly be use around the date of event all showed compliance to specifications and no microbial growth or defects were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031227-2013-00001 |
| MDR Report Key | 3108813 |
| Report Source | 99 |
| Date Received | 2013-05-06 |
| Date of Report | 2013-05-06 |
| Date of Event | 2010-07-27 |
| Date Mfgr Received | 2013-04-05 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-05-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARY MOCNIK |
| Manufacturer Street | 49 COASTAL OAK |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Street | 2277 REDONDO AVE. |
| Manufacturer City | SIGNAL HILL CA 90755 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90755 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRAFACIAL |
| Generic Name | GFE, HYDRADERMABRASION |
| Product Code | GFE |
| Date Received | 2013-05-06 |
| Model Number | HYDRAFACIAL WAVE |
| Catalog Number | 70159-03 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDGE SYSTEMS LLC |
| Manufacturer Address | SIGNAL HILL CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-06 |