MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE LYFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 18277

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Erythema (1840); Inflammation (1932); Pain (1994); Discomfort (2330); Easy Bruising (4558); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious events of cellulitis and inflammation at implant site, and the non-serious events of pain, swelling, erythema, warmth, bruising, induration at implant site and discomfort at injection site were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.Potential root causes are the treatment procedure and injection procedure associated with inadequate aseptic technique.Potential contributory factor include pfizer covid-19 vaccine.The non-serious events of feeling abnormal and tenderness were considered unexpected, unrelated to the treatment.No treatment was performed to affected area.Alternative etiology include undiagnosed medical conditions.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a nonconforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a (b)(6) female patient, concerning herself.Additional information was received on (b)(6) 2021 from patient herself.The patient's medical history included hashimoto's disease, hypothyroidism, add, port wine stain birthmark on right cheek, dental cleaning.Alleries to diflucan and latex.The patient had previously received treatment with restylane.Concomitant treatments included armour thyroid medication [armour thyroid] for hypothyroidism and methylphenidate xr [methylphenidate] for add.On (b)(6) 2020, the patient received treatment with 2 ml restylane lyft with lidocaine (lot 18277) to cheeks and temples and 1 ml restylane defyne (lot 18151) to nasolabial folds and marionette lines using an unknown injection technique and needle type.Within a week of the injection, on an unknown date in (b)(6) 2020, the patient's back of neck and skull got really tender(tenderness) which she described as the feeling when lay head in a bowl at the hairdressers.The patient was also experiencing brain fog(feeling abnormal) during a couple of weeks following the injection.The patient was prescribed a salicylic acid [salicylic acid] shampoo, she started to feel better and resolved.Unknown time later, on an unknown date in (b)(6) 2021, the patient woke up in the morning and she had some pressure(injection site discomfort) under her left eye, on the top of cheekbone up to the under the eyebrow.She reported that the pressure would come and go.On an unknown date in the beginning of (b)(6) 2021, the patient woke up and felt the pressure.Then the left side of her face started swelling(implant site swelling).The patient went to see an infectious disease hcp, who sent her for a head and neck ct which showed cellulitis(implant site cellulitis), diagnosed her with periorbital cellulitis.The hcp prescribed a 2 week course of doxycycline [doxycycline].The patient reported that the events were resolving but right before she was about to take her last dose, the left side of her face started to become inflamed(implant site inflammation) again.Also there was swelling, redness(implant site erythema), warm to touch(implant site warmth) and tender(implant site pain).She felt her cheekbones were bruised(implant site bruising) and also felt like stone placed under skin(implant site induration) of left cheekbone.The hcp had prescribed another 2 week dose of doxycycline and a similar thing happened.On (b)(6) 2021, the patient received first dose of pfizer covid-19 vaccine.On (b)(6) 2021, the patient received second dose of pfizer covid-19 vaccine.The patient reported it was getting better and then right before her last dose of pfizer covid-19 vaccine, she experienced the inflammation, along with the swelling, redness, tender, warm to the touch, cheekbones feeling bruised and stone under the skin again.On an unknown date in 2021, the hcp then prescribed patient a 3 day course of keflex [cefalexin] and there was no improvement.On an unknown date in 2021, the hcp then prescribed 13 days of infusion treatment, 350mg of daptomycin [daptomycin].Again her side effects started to get better and then re-emerged.Currently, the patient was receiving another course of infusion treatment with 500mg of daptomycin.On an unknown date in 2021, the patient had contacted injecting hcp, who recommended patient to come to office, but patient did not visit hcp office.Outcome at the time of the report: cellulitis was unknown.Inflamed was not recovered/not resolved.Back of neck and skull got really tender was recovered/resolved.Brain fog was recovered/resolved.Pressure was not recovered/not resolved.Swelling was not recovered/not resolved.Redness was unknown.Warm to touch was not recovered/not resolved.Tender was not recovered/not resolved.Bruised was not recovered/not resolved.Felt like stone placed under skin was not recovered/not resolved.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 12001436
• MDR Text Key: 256290157
• Report Number: 1000118068-2021-00019
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 18277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Other
• Date Report to Manufacturer: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID MEDICATION (THYROID) DAILY; METHYLPHENIDATE XR (METHYLPHENIDATE) DAILY; PFIZER COVID-19 VACINE; PFIZER COVID-19 VACINE; RESTYLANE DEFYNE
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR