FDA.reportPublic FDA data

MAUDE MDR 5335340

MDR report key
5335340
Report number
MW5058791
Event key
0
Event type
3
Date of event
2015-12-17
Date received
2015-12-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BEAUTY ANGELBEAUTY ANGELJK PRODUCTS & SERVICES, INC.LEJ* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-290

Event Narratives#

D

Patient 1

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.