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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.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key11408125
MDR Text Key242207553
Report Number1000118068-2021-00006
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
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 Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2021
Distributor Facility Aware Date03/09/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/03/2021 Patient Sequence Number: 1