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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA LABORATORIES, L.P. RESTYLANE FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA LABORATORIES, L.P. RESTYLANE FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problem Discomfort (2330)
Event Date 06/22/2021
Event Type  malfunction  
Event Description
Product was not fully used; i walked in the office with an uncomfortable feeling. The front desk was not answering the phone calls when i was waiting to be seen. The lady was trying to offer me products and commenting me negatively on the previous injector i have visited. She injected on my cheeks 4 times and i noticed the whole syringe wasn't used. While she was saying that i finished the treatment. I told her that it was really quick and that the syringe wasn't used fully. She fully ignored me and told me to look at the mirror for the results. The results were the same as before i started the treatment. I paid so much for a treatment that wasn't used properly. When i left and tried calling back to speak with the injector nobody picked up and i called 20 times. When i received a phone call after a couple hours the guy was very disrespectful on the phone saying and what's the problem after i stated that the injector didn't do her work properly. I said i will report them and he said to go do that in a very nasty way. I am truly dissatisfied. She has taken my money for a treatment that didn't even work. Very little of the restalyne filler was used. She diluted the substance. I am really disappointed and would like a refund for the pointless treatment.
 
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Brand NameRESTYLANE FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA LABORATORIES, L.P.
MDR Report Key12066861
MDR Text Key258888225
Report NumberMW5102147
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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