BELLAFLASH BY SILK'N LASER BELLA FLASH AS102275A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for BELLAFLASH BY SILK'N LASER BELLA FLASH AS102275A manufactured by Homeskinovations.

Event Text Entries

[35063897] I purchased and used the bella flash by silk'n- laser hair removal device according to the device manual instructions. The manual said that the bella flash can be used to treat facial hair, but caution should be used around eyes. It said it has a built in safety device for eye protection. According to the manual it says, it has been designed so that the light pulse can not be admitted when the treatment surface is facing open air. The safety switch enable treatment only when the treatment surface is in contact with the tissue. My device must be defective because it went off 2 times when not in contact with tissue which was a surprise. The first time it flashed when held away from my body by 180 degrees so it flashed out into space onto a wall about one foot away. So no direct flash into my eyes. The second time i had turned the device 180 degrees away from my face and as i was turning it toward my face, it went off directly into my face. At a distance of only 6 inches from my face, but definitely not in contact. Again shocked and surprised that it would flash without contact and directly into my face at eye level. I had purchased protective laser eye wear prior to using this device just as a safety precaution. I was wearing them in both cases. To be safe, i did see my eye doctor the next day to make sure there was no damage. He and his assistants did a full eye exam. At that time he did not think there was because i was wearing protective eye glasses and thought discontinuing use of this device was a good idea. I think my device was defective and hope there are no long term effects to having a laser flashed directly into my eyes even with protective eye wear. I hope the fda examines this product for safety. What if others use it and the laser flashes when not in contact with the skin and they are not wearing protective eye wear?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058853
MDR Report Key5341293
Date Received2015-12-29
Date of Report2015-12-29
Date of Event2015-11-29
Date Added to Maude2016-01-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBELLAFLASH BY SILK'N LASER
Generic NameBELLAFLASH BY SILK'N LASER
Product CodeOHT
Date Received2015-12-29
Model NumberBELLA FLASH
Catalog NumberAS102275A
ID NumberPK107155B
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOMESKINOVATIONS


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-29

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