BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTALYNE LYFT

    MDR report key: 15527852 · Received September 30, 2022

    Report

    Report Number
    MW5112375
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    May 27, 2022
    Report Date
    September 25, 2022
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I DEVELOPED HAIR LOSS AFTER BEING INJECTED WITH RESTYLANE DERMAL FILLER IN MY TEMPLES ON (B)(6) 2022. WITHIN HOURS I HAD BURNING PAIN. I TOOK ADVIL AND APPLIED AMICA CREME. AFTER 3 DAYS THE BURNING PAIN CONTINUED ON THE RIGHT SIDE OF MY HEAD IN LINE WITH MY TEMPLE. I CALLED THE ON CALL DR SHE SUGGESTED ARNICA AND OVER THE COUNTER PAIN RELIEF. SHE BOOKED AN APPOINTMENT WITH MY DERMATOLOGIST WHO HAD GIVEN THE RESTALYNE LYFT INJECTIONS. THE DR DESCRIBED ENCRUSTED SCARING ON MY RIGHT SCALP. SHE ASKED ME TO CONTINUE AMICA. ON MY NEXT VISIT (B)(6), THE SCABS HAD FALLEN OFF WITH MY HAIR. I HAD A BALD PATCH ON MY RIGHT SIDE. PHOTO IN DR'S NOTES. ON (B)(6) THE SAME DR ADMINISTERED LNTRALESIONAL KENALOG INJECTIONS. WE DISCUSSED USING ROGAINE 5% TWICE DAILY. ON (B)(6) THE HAIR LOSS HAD NOT HEALED. THE BALD PATCH REMAINED. SHE INJECTED A SECOND SHOT 3..0 MG/CC OF KENALOG. SEE DR'S NOTES ENCLOSED. THREE WEEKS LATER WE DID A THIRD SHOT. I STILL USED ROGAINE 2X A DAY. NO CHANGE WAS EVIDENT. I THEN TRIED ACUPUNCTURE TO INCREASE BLOOD FLOW TO THE BALD AREA. I HAVE ENCLOSED THE ACUPUNCTURISTS FILE NOTES. THE ACUPUNCTURIST TREATED ME FOR SCARING ALOPECIA FROM (B)(6) 2022 TO NOW (B)(6) 2022. DURING THIS TIME I CONTINUED WITH ROGAINE 2X A DAY. AS OF (B)(6) 2022 THERE HAS BEEN NO CHANGE OR RESOLUTION TO THE INJURY. AFTER 4 MONTHS THE DR HAS CONCLUDED THAT THIS DAMAGE IS PERMANENT. WAS DIAGNOSED WITH SCARING ALOPECIA. ENCLOSED DERMATOLOGIST NOTES WHO ADMINISTERED THE RESTALYNE LYFT INJECTIONS. ENCLOSED ACUPUNCTURE TREATMENTS NOTES FOR PARTIAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417953 RESTALYNE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P. 20070

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Disability FISH OIL | IRON | VIT C