MAUDE Adverse Event Report: PREMIER NORTH AMERICA, INC. AVOLOGI ENEO ADVANCED; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number EN0900515123

Device Problem Defective Component (2292)

Patient Problems Erythema (1840); Reaction (2414)

Event Date 08/01/2019

Event Type  Injury  

Event Description

After using the avologi eneo face product, i had a strong reaction on a previous pre-skin cancer mark.It came up red and then crushed up.I was told the product would wrinkles and brown spots - but i did not expect to get this reaction within 2/3 weeks of using the product, which i purchased on (b)(6) 2019 at the (b)(6).The retailer would not answer calls, nor would the usa distributor (b)(4).Additionally, the 2 adaptors provided by the store are defective, and do not fit the usa wall plug, and could be potentially dangerous if used in the (b)(6) or europe.I am concerned the product sold to me may not be the product that has received fda approval - ie the packaging looks good, but am now unsure of the actual product inside the package is the correct one.I wished and tried to contact the (b)(4) mfr, via the distributor, to no avail.There is only a vague distributor centre park based in (b)(4).How can a product approved by the fda have no info on the mfr and no way to ask questions or have the defective parts repaired or replaced.A product which has a laser involved needs to satisfy the customer that it has integrity, and is indeed the product approved by the fda.Fda safety report id# (b)(4).

• Brand Name: AVOLOGI ENEO ADVANCED
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): PREMIER NORTH AMERICA, INC.
• MDR Report Key: 8992646
• MDR Text Key: 158638100
• Report Number: MW5089717
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EN0900515123
• Device Catalogue Number: 000
• Device Lot Number: 000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54