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

Lot Number UNKNOWN

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

Patient Problems Anaphylactic Shock (1703); Purulent Discharge (1812); Dyspnea (1816); Ecchymosis (1818); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Dizziness (2194); Skin Infection (4544); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of anaphylactic reaction and the non-serious events of dizziness and dyspnoea were considered unexpected and unrelated to the treatment.Serious criteria include life threatening condition and the need for urgent medical care, and treatment with epipen, benadryl and intravenous steroids.The likely root cause for anaphylactic reaction, dizziness and dyspnoea include immediate hypersensitivity to pfizer covid vaccine.The serious expected event of infection at implant site, the non-serious expected events of bruising, pain, induration, swelling, discolouration at implant site and purulent discharge and the non-serious unexpected event of weight decreased were considered possibly related to the treatment.Serious criteria includes the need for medical intervention to prevent permanent damage including multiple antibiotic courses.Potential root causes for the events at the implant site include the treatment procedure and inadequate aseptic technique during the injection leading to infection and its manifestations.A likely root cause for the weight loss included decreased ability to eat or drink due to pain and limited jaw mobility secondary to cheek infection.The case met the seriousness criteria for expedited reporting to 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.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming 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 02-feb-2021 by a (b)(4) -year-old female physician patient, concerning herself.Additional information was received on 04-feb-2021 from the patient herself.The patient's medical history included scar on cheek, asthma, allergic to pollen and dust.The patient does not routinely use any other products or medications.The patient had previously received treatment with juvederm voluma 2-3 years ago that was injected in the same area for treatment of her scar and to look better.She had a similar reaction on the left cheek which was not as severe as the reaction she was currently having.The patient mild to moderate infection, huge hole on the cheek area and swelling.There was a little bit of a dent on the face.The reaction went from her ear to nose area.At that time, patient was told she was allergic to hyaluronic acid, which she did not believe as she had unspecified fillers before and never had a reaction.The hcp told her that there were two options, one option was restylane lyft and other one was surgery.The patient had received flu vaccine in last (b)(6) 2020 and shingles vaccine around (b)(6) or (b)(6) 2020.The patient had not experienced any illness in the month prior to treatment and no dental procedures in the past 6-12 months.On (b)(6) 2021, the patient received treatment with 2 injections of restylane lyft with lidocaine to the left cheek area for treatment of a scar (unknown amount, lot number, injection technique and needle type).Almost immediately, on (b)(6) 2021, the patient was swollen(implant site swelling), could not open her mouth.She had pain(implant site pain) and it felt hard as a rock/cyst like a rock (implant site induration).The patient bruised(implant site bruising) and for two weeks that area was black(implant site discolouration).The bruising had resolved.The patient was advised to apply ice and hot pad.On (b)(6) 2021, the patient went to urgent care and was given an injection of an unspecified antibiotic and oral antibiotics to take at home.On (b)(6) 2021, the patient reported that she could not eat, could not open her mouth and could not event drink water due to severe pain.The patient also experienced weight loss (weight decreased).The patient was started on 2 weeks unspecified antibiotics.23 days later, on (b)(6) 2021, the scar area that was injected with restylane lyft with lidocaine burst open and drained yellow fluid(purulent discharge).She did not seek medical treatment but was still on oral antibiotics.She continued to have pain and swelling and inability to open her mouth and talk clearly.On (b)(6) 2021, the patient received the pfizer covid vaccine and immediately, the patient had an anaphylactic reaction(anaphylactic reaction) described as difficulty breathing (dyspnoea) and dizziness(dizziness).The patient was treated with an epipen [epinephrine], benadryl [diphenhydramine hydrochloride], and iv steroids.While she was being observed in the er patient requested and was given iv antibiotics for her infection(implant site infection) at her scar.After 7 hours she was released.The patient had scheduled a follow-up appointment with her injecting physician next week for her continued pain, swelling and inability to move her mouth and talk properly.The patient was encouraged to seek out medical care earlier since she was experiencing pain, but she declined.Outcome at the time of the report: anaphylactic reaction was unknown.Swollen was not recovered/not resolved.Pain was not recovered/not resolved.Bruised was recovered/resolved.Area was black was recovered/resolved.Felt hard as a rock/cyst like a rock was not recovered/not resolved.Weight loss was unknown.Drained yellow fluid was unknown.Dizziness was unknown.Difficulty breathing was unknown.Infection was unknown.Tracking list: v.0 initial.V.1 fu received on 10-feb-2021, 11-feb-2021 and 12-feb-2021 from the patient herself: case upgraded to serious.Events (anaphylactic reaction, area was black, drained yellow fluid, dizziness, infection and difficulty breathing) added.Event coding changed from implant site mass to implant site induration.Event off label use deleted.Medical history, past filler treatment, concomitant pfizer covid vaccine, suspect device implant location, event onset date, location and corrective treatment details were updated.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of infection at implant site, the non-serious expected events of bruising, pain, induration, oedema, discolouration, hypersensitivity, erythema at implant site and purulent discharge and the non-serious unexpected event of weight decreased were considered possibly related to the treatment.Serious criteria includes the need for medical intervention including multiple antibiotic courses to prevent permanent damage.Potential root causes for the events at the implant site include the treatment procedure and inadequate aseptic technique during the injection leading to infection and its manifestations.A likely root cause for the weight loss included decreased ability to eat or drink due to pain and limited jaw mobility secondary to cheek infection.The serious event of anaphylactic reaction and the non-serious events of dizziness and dyspnoea were considered unexpected and unrelated to the treatment.Serious criteria include life threatening condition and the need for urgent medical care including treatment with epipen, benadryl and intravenous steroids.The likely root cause for the anaphylactic reaction, dizziness and dyspnoea include immediate hypersensitivity reaction to pfizer covid vaccine.The case met the seriousness criteria for expedited reporting to 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.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.The reported number of 011401 was the article number, which corresponds to the product restylane lyft with lidocaine.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 02-feb-2021 by a 69-year-old female physician patient, concerning herself.Additional information was received on 04-feb-2021 from the patient herself.The patient's medical history included atrophic scar on left cheek in the region of drainage that was attempted to correct, asthma, allergic to pollen, dust, penicillin, latex and morphine.The patient does not routinely use any other products or medications.The patient had previously received treatment with juvederm voluma 2-3 years ago that was injected in the same area for treatment of her scar and to look better.She had a similar reaction on the left cheek which was not as severe as the reaction she was currently having.The patient had mild to moderate infection, huge hole on the cheek area and swelling.There was a little bit of a dent on the face.The reaction went from her ear to nose area.At that time, patient was told she was allergic to hyaluronic acid, which she did not believe as she had unspecified fillers before and never had a reaction.The hcp told her that there were two options, one option was restylane lyft and other one was surgery.The patient had received flu vaccine in last (b)(6) 2020 and shingles vaccine around a (b)(6) 2020.The patient had not experienced any illness in the month prior to treatment and no dental procedures in the past 6-12 months.On (b)(6) 2021, the patient received treatment with 2 ml restylane lyft with lidocaine (unknown lot number), 1.8 ml to cheeks, 0.2 ml to bilateral marionette area with unknown needle type and injection technique periosteally.The patient had no issues in nasolabial folds but very small amount administered in that area.The reported number of (b)(4) was the article number, which corresponds to the product restylane lyft with lidocaine.Almost immediately, on (b)(6) 2021, the patient had swollen/edema (implant site oedema) in the left cheek scar, could not open her mouth.A mild subcision was completed with the filler needle and it was felt her edema was due to this.She had erythema(implant site erythema) and it felt hard as a rock/cyst like a rock (implant site induration).The patient bruised(implant site bruising) and for two weeks that area was black(implant site discolouration).The bruising had resolved.The patient was advised to apply ice and hot pad.2 days later, on (b)(6) 2021, the patient developed pain(implant site pain) and edema.On (b)(6) 2021, the patient went to urgent care and was given an injection of an unspecified antibiotic.The patient was given clindamycin [clindamycin] 300 mg orally twice a day from (b)(6) 2021 as precaution.On (b)(6) 2021, the patient reported that she could not eat, could not open her mouth and could not event drink water due to severe pain.The patient also experienced weight loss (weight decreased).The patient was started on 2 weeks unspecified antibiotics.23 days later, on (b)(6) 2021, the scar area that was injected with restylane lyft with lidocaine burst open and drained yellow fluid(purulent discharge).She did not seek medical treatment but was still on oral antibiotics.She continued to have pain and swelling and inability to open her mouth and talk clearly.The patient was given doxycycline [doxycycline] 100 mg orally twice a day from (b)(6) 2021.On (b)(6) 2021, the patient received the pfizer covid vaccine and immediately, the patient had an anaphylactic reaction(anaphylactic reaction) described as difficulty breathing (dyspnoea) and dizziness(dizziness).The patient was treated with an epipen [epinephrine], benadryl [diphenhydramine hydrochloride], and iv steroids.While she was being observed in the er patient requested and was given iv antibiotics for her infection(implant site infection) at her scar.After 7 hours she was released.The patient was advised not to get the covid vaccine until her reaction improved but patient received the vaccine anyway.The patient had scheduled a follow-up appointment with her injecting physician next week for her continued pain, swelling and inability to move her mouth and talk properly.The patient was encouraged to seek out medical care earlier since she was experiencing pain, but she declined.On an unknown date in 2021, the patient underwent culture to rule out infection and result was negative.It was felt that patient had hyaluronic acid allergy(implant site hypersensitivity).The patient was improved.Outcome at the time of the report: anaphylactic reaction was recovering/resolving.Infection was recovering/resolving.Swollen/edema was recovering/resolving.Pain was recovering/resolving.Bruised was recovered/resolved.Area was black was recovered/resolved.Felt hard as a rock/cyst like a rock was recovering/resolving.Erythema was recovering/resolving.Weight loss was recovering/resolving.Drained yellow fluid was recovering/resolving.Dizziness was recovering/resolving.Difficulty breathing was recovering/resolving.Hyaluronic acid allergy was recovering/resolving.Tracking list: v.0 initial v.1 fu received on 10-feb-2021, 11-feb-2021 and 12-feb-2021 from the patient herself: case upgraded to serious.Events (anaphylactic reaction, area was black, drained yellow fluid, dizziness, infection and difficulty breathing) added.Event coding changed from implant site mass to implant site induration.Event off label use deleted.Medical history, past filler treatment, concomitant pfizer covid vaccine, suspect device implant location, event onset date, location and corrective treatment details were updated.V.2 fu received on 09-mar-2021 and 12-mar-2021 from the same physician.Events (erythema and hyaluronic acid allergy) added.Event coding changed from implant site swelling to implant site oedema.Medical history, suspect device volume, location, event outcome, severity, reporter causality and corrective treatment details were updated.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11408125
• MDR Text Key: 242207553
• Report Number: 1000118068-2021-00006
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Distributor Facility Aware Date: 03/09/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVID VACCINE - PFIZER; COVID VACCINE - PFIZER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR