FDA Adverse Event Injury Summary report: N

IMPLANT, DERMAL, FOR AESTHETIC USE

MDR report key: 19595810 · Received June 21, 2024

Report

Report Number
MW5156503
Event Type
Injury
Date Received
June 21, 2024
Date of Event
May 23, 2024
Report Date
June 19, 2024
Manufacturer
GALDERMA LABORATORIES, L.P.
Product Code
LMH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
HI, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WENT TO A SCHEDULED APPOINTMENT AT (B)(6) LOCATED AT (B)(6) FOR SCULPTRA FILLER FOR CHEEKS. THE INJECTOR (B)(6) HAS DONE THIS PROCEDURE SEVERAL TIMES IN THE PAST FOR ME, WITHOUT ANY PROBLEMS. THIS NURSE DID SOMETHING DIFFERENT THAN SHE HAD IN THE PAST. THE FOLLOWING MORNING, MY FACE WAS SOAR/PAINFUL AND MY FOREHEAD WAS NUMB, EYES WERE NOT FEELING RIGHT. MY EYES FELT HEAVY AND SLIGHTLY SWOLLEN. MY SKIN FELT, AND STILL DOES, VERY DRY, BURNING PAIN WITH LITTLE NEEDLE LIKE SENSATION. TODAY, (B)(6) 2024, THE SYMPTOMS HAVE NOT GOTTEN BETTER, BUT CONTINUE AND MY SKIN IS AND HAS BEEN SUPER DRY, PAINFUL WITH A BURNING SENSATION. MY LEFT EYE DEVELOPED A TWITCHING ON MY EYELID, AND THIS LASTED FOR SEVERAL DAYS. MY FOREHEAD STILL FEELS STRANGE. MY TONGUE HAS A METALLIC TASTE. I CONTACTED THE NURSE THE FOLLOWING DAY TO EXPLAIN WHAT I AM FEELING AND SHE PRETTY MUCH DISMISSED ME AND HAS NOT EVEN CALLED TO SEE HOW I AM DOING. SHE DID PRESCRIBE METHYLPREDNISOLONE 4MG FOR THE UNUSUAL SWELLING I WAS EXPERIENCING. I BELIEVE THAT I WAS INJECTED WITH SOMETHING OTHER THAN SCULPTRA, AND I AM CONCERNED THAT I HAVE BEEN POISONED. AFTER CONTACTING THIS NURSE AND REPORTING MY SYMPTOMS TO HER, ALL SHE SAID WAS SOMETHING TO THE EFFECT: SORRY YOU HAD A BAD EXPERIENCE. I ASKED FOR THE INFORMATION AND WOULD LIKE TO KNOW IF THIS IS LEGITIMATE SCULPTRA - GALDERMA LOT NUMBER: 3J4402, EXP: 9.30.36. I AM CONCERNED AND NOT SURE WHAT TO DO WHEN I FEEL THAT I WAS DECEIVED MY A PROFESSIONAL WHO HAS. PLEASE ADVISE WHAT I SHOULD DO, THANK YOU!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1157221 IMPLANT, DERMAL, FOR AESTHETIC USE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P. 3J4402

Patients

Seq Age Sex Outcome Treatment
1 66 YR Female VITAMIN B.| VITAMIN C.