FDA Adverse Event Malfunction Summary report: N

RESTYLANE FILLER

MDR report key: 12066861 · Received June 24, 2021

Report

Report Number: MW5102147
Event Type: Malfunction
Date Received: June 24, 2021
Date of Event: June 22, 2021
Report Date: June 23, 2021
Manufacturer: GALDERMA LABORATORIES, L.P.
Product Code: LMH
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: NY, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
959981	RESTYLANE FILLER	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	GALDERMA LABORATORIES, L.P.

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR		Other