BEAUTY ANGEL

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 BEAUTY ANGEL manufactured by Jk Products & Services, Inc..

Event Text Entries

[34798661] Pt called to report an adverse reaction on (b)(6) 2015, to a device called beauty angel. Pt stated, she used the device at a local plant fitness, and nowhere did she see any warning that said to wear eye protection when using the device. Pt said on (b)(6) 2015, she was driving and noticed vision changes. Pt said all the lights on the road were glaring, her peripheral vision was blurry, and she developed a headache. Pt said the corners of her eyes felt very painful, and that the skin around her eyes was sore. On (b)(6) 2015, the pt said she finally realized her vision changes were getting worse so she went to see an eye doctor. She said the eye doctor confirmed her vision changes, but could not confirm if the damage was temporary or permanent. Pt said she was referred to a retina specialist, but has not been able to schedule an appointment yet. The pt also said the skin on her face changed, her freckles became more noticeable, even though she had put a t-shirt over her face.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058791
MDR Report Key5335340
Date Received2015-12-29
Date of Report2015-12-29
Date of Event2015-12-17
Date Added to Maude2015-12-30
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 NameBEAUTY ANGEL
Generic NameBEAUTY ANGEL
Product CodeLEJ
Date Received2015-12-29
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerJK PRODUCTS & SERVICES, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-29

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