ANTI - WRINKLE LIGHT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for ANTI - WRINKLE LIGHT manufactured by Unk.

Event Text Entries

[109655096] At the (b)(6) of optometry in (b)(6) as a speaker, as well as managing the booth for the national academy of opticianry, i was hobbling to the booth (on a walker due to a recently fractured leg) when an insistent young man approached me if i wanted to try a free sample of their products. I am accustomed to free samples given out the hundreds of eye care conferences. He began applying a cream to my lower lids. First, i was quite disturbed that he applied this product without washing his hands. He then very quickly grabbed a fan to "dry" the product and kept telling me how great it worked and that his auntie used it and she loved it. He kept shoving a mirror in my face and telling me that i looked wonderful but without my glasses i could not tell. I told him i only use natural "fragrance free" product as i am very sensitive, and he assured me they were. Then he said i was so lucky because the product he used on me was normally (b)(6) but the show price was only (b)(6). He then tried to sweeten the pot by throwing in several more product. He claimed the total value was over (b)(6). I was in a hurry and figured what the heck his booth was around the corner from ours and i could observe that evening if the product worked, if not, catch him in the morning for a refund. That night the entire left side of my face was numb, and i had a red rash on the right side of my face where he had tried some sort of anti-wrinkle "light" device that he also tried to sell me for an add'l (b)(6). I arrived at the convention center early the next morning and approached one of the sales associates and explained what happened. She was extremely defensive of the products, but did tell me there would be no problem with the refund, but i had to wait till her boss arrived. Later (b)(6) approached me at our booth. I suggested we talk away from the booth and approached a bench across the way, so i could sit as i was supposed to have reduced weight on my leg. After graciously explaining what happened to my face the night before with the numbness and rash, he became very defensive and claimed the rash was not from the products he sold me but one he used on me after he tried the "wrinkle erasing" light that i did not purchase. He went on to explain that as the buyer it was my responsibility to keep the products even if they didn't work. He showed me his watch which he claimed was a (b)(6) worth (b)(6) (he went on to explain if there had been anything wrong with it, he would not bring it back because it was his responsibility. He kept telling me i signed the bill that said no refunds. I explained he had me sign on his (b)(6) with an electronic signature and that he never showed me the clause stating there were no refunds. I explained that i would never have purchased the products without the ability to return them. He told me there was nothing he could do. I explained i was on social security and fixed income and because of the reaction i could not afford to pay for something i could never use. I was devastated, i have never in my (b)(6) been treated so rudely and unprofessionally. These sales people are independent reps that work for this company, they probably have very little training in cosmetology or pharmacology. I was sold products that do not work as promised: i had a reaction to two of the products; i was lied to about the ingredients and results; the product was applied with unwashed hands; other products were applied to me that were opened which could have provided cross-contamination if another person had any kind of skin disease; i was refused a refund because i did not read a bill of sale that was never explained if you work with people using cosmetic products applied to the skin you must wash your hands or wear gloves. That was never done. You must make certain the products applied or re-applied meet clean standards. I reported to the (b)(6) and company website and complaints page. Not willing to risk chance of recurrence so i did not use product again. Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018. Reason for use: under eye puffiness.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077485
MDR Report Key7552935
Date Received2018-05-29
Date of Report2018-05-26
Date of Event2018-03-12
Date Added to Maude2018-05-30
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 NameANTI - WRINKLE LIGHT
Generic NamePOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT
Product CodeONE
Date Received2018-05-29
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-29

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