MAUDE Adverse Event Report: FILLERS; IMPLANT, DERMAL FOR AESTHETIC USE

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Distress (2329)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, i went to (b)(6) at his dentist/clinic to have fillers which i was told would last 2 years.The cost was 900 pounds sterling, which at the time i felt was expensive but thought i was getting my money's worth and i was going through a difficult time due to my mother passing which her funeral was on the (b)(6), and he knew of this.As i'd had botox done weeks before and i had to go back to get them done again.I went to my mother's funeral and come back a few days later, and noticed my face was back to normal.I contacted him and i made an appointment to see him again, and that resulted in him lying, saying there was nothing wrong with my face, deleting pictures of me off his record and shouting at me which my daughter and daughter's father could hear in the reception.He offered me a 375 pounds sterling refund, i denied as he made no difference to my face and i wanted the whole lot back, he got very angry and kept on saying i asked for 6 months worth when i said 2 years worth.He kept getting confused on what he had done and had to keep looking at the paper he was holding, he would not let me see it, i felt betrayed and lied to and also made my self-confidence worse, i am disabled and this has caused me a lot of pain and stress on my body as i had saved up a long time for this.He also gave me a numbing injection which you give when you're having your teeth out he was very rough in doing this as it hurt a lot and i can take a lot of pain.I found this out due to other people in the same industry saying this was incorrect, and i had paid way over the top.When i did go back to him he asked if i had enjoyed my holiday when he knew was a funeral.I had taken this to the general dental council, with no joy as they deal with dentistry.I have missed out a lot but please contact me (b)(6).I hope you understand this as disabled find it quite hard relay as my mind works differently.Thank god grammar help.Regards carolyn franklin.I have all e-mails and notes.

• Brand Name: FILLERS
• Type of Device: IMPLANT, DERMAL FOR AESTHETIC USE
• MDR Report Key: 7472696
• MDR Text Key: 107203157
• Report Number: MW5076895
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 58