MAUDE Adverse Event Report: BIOPHOTAS, INC. BIO PHOTAS CELLUMA DELUXE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number CDLX-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/12/2021

Event Type  Injury  

Event Description

We used the celluma deluxe as instructed and the treatment resulted in photodermatitis.We immediately sent the photos to bio photas-celluma.No assistance was offered to return the device or receive a refund of our monies.Our physician sent a letter stating we could not use the device and instructed it should be returned.No assistance once again from bio photas-celluma.We contacted bio photas- celluma once again, yesterday after speaking with the fda complaint department over the phone.We requested the model number to allow the fda to do an investigation-and we did receive the device model number this morning from bio photas- celluma-nothing more, only the model number cdlx-001.Total payment to bio photas- celluma (b)(6) 2021.Thank you to the fda for assisting us and many other consumers over the years, we are extremely appreciative! fda safety report id# (b)(4).

• Brand Name: BIO PHOTAS CELLUMA DELUXE
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): BIOPHOTAS, INC.
• MDR Report Key: 14632949
• MDR Text Key: 293708795
• Report Number: MW5110184
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2022

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: CDLX-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2022
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White