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

Lot Number UNKNOWN

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

Patient Problems Abdominal Pain (1685); Erythema (1840); Fatigue (1849); Headache (1880); Nausea (1970); Rash (2033); Hot Flashes/Flushes (2153); Discomfort (2330); Malaise (2359); Eye Pain (4467); Skin Inflammation/ Irritation (4545); Nodule (4551); Implant Pain (4561); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious event of swelling at implant site and the non-serious expected events of pain, induration, erythema, mass, warmth and inflammation at implant site and injection site discomfort were considered expected and possibly related to the treatments.Serious criteria include permanent damage and multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure.Potential contributory factor includes concomitant vaccine administration.The non-serious unexpected events of influenza like illness, fatigue, headache, eye pain, rash, nausea, ocular hyperaemia, flushing, swelling of eyelid, abdominal discomfort, erythema of eyelid, migraine, malaise, pain, feeling hot and decreased appetite were considered unrelated to the treatments.Alternative root cause for these events includes community acquired infection and its manifestation.The case meets the criteria for expedited reporting to the regulatory authorities.Manufacturer note: 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 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 15-jun-2021 by a physician which refers to a (b)(6 years-old female patient.Additional information was received on 16-jun-2021 from the physician and on 17-jun-2021 from the patient herself.The patient medical history included coronary artery disease (cad), angina, slightly ectatic (narrowing) thoracic aorta and osteoarthtritis.The patient had stent in left anterior descending artery in (b)(6).The concomitant medications included unspecified heart medication, unspecified nitrates, unspecified statins, estradiol [estradiol], unspecified blood thinners, iron pills[iron] and unspecified vitamins [vitamins nos].The patient had no known allergies and had previously used botox, restylane, juvederm (10-12 years ago) and unspecified nivol filler (unsure of exact name).On an unknown date in (b)(6) 2019 (around (b)(6) 2019), the patient received treatment with restylane (unknown amount, lot number, injection technique and needle type) to the bilateral nlf and bilateral marionette lines for an unknown indication.On an unknown date in (b)(6) 2019 (around (b)(6) 2019), the patient also received treatment with restylane lyft (unknown amount, lot number, injection technique and needle type) to nasolabial folds, cheekbones for an unknown indication.Unknown time later, on an unknown date between (b)(6) 2019 or (b)(6) 2019, the patient experienced swelling(implant site swelling) to bilateral nasolabial folds and marionette lines.The patient stated that initially her skin was little pink/red (implant site erythema), hard (implant site induration) and a little bit swollen.The swelling always started on the left side and as the left sided swelling resolved after about 5-6 days, the right side of the face begins to swell and then the swelling resolved completely.Initially, the swelling would rise and face felt warm (implant site warmth) and was not too painful (implant site pain) but was uncomfortable (injection site discomfort).After a couple of days the swelling would go down.On an unknown date in 2020, the patient had received flu shot and pneumococcal pneumonia vaccine.After (b)(6) 2020, the swelling attacks started more frequently, became more intense and more painful.The patient informed that initially the swelling attacks were every 5-6 weeks and later they started occurring every 10 days to 2 weeks.On an unknown date in 2020, during these attacks, the patient had flu like symptoms (influenza like illness), felt tired (fatigue), achy neck, shoulders and sometimes lower back would hurt (pain).The patient also stated that her eyes would get a little bloodshot (ocular hyperaemia), face would get flushed (flushing), upper body felt hot (feeling hot) and also experienced a pounding headache(headache) during the attacks.The patient had also developed migraines(migraine) and was feeling generally unwell (malaise).On (b)(6) 2020, the patient experienced first rash that looked like dermatitis contact (rash) to both arms, from elbow to wrist and also to the top of the arms extending back toward shoulder and the second rash was on (b)(6) 2020.The patient was treated with antihistamines[antihistamines] and steroids to treat rash to arms.On an unknown date, the rash had resolved.The reporting physician stated that the patient was treated with numerous z-pak [azithromycin] and hyaluronidase [hyaluronidase] to try to dissolve the product.The patient had an extended period without swelling, however the swelling returned and further attempts to treat with z-pak and hyaluronidase without success.On an unknown date, the patient underwent a ct scan (findings unknown to patient) and was advised to see an ent.The patient also underwent an mri test and result showed product in the swelling region.The patient had received first and second dose of moderna covid-19 vaccine on (b)(6) 2021 and (b)(6) 2021 respectively.On an unknown date in (b)(6) 2021, the patient woke up one morning with flu like symptoms, her eyes were puffy (swelling of eyelid ), eye pain (eye pain) and her eyelids were red(erythema of eyelid) and she could not open the eyes.On an unknown date in 2021, the left side of the face swelled again which was resolving after 5-6 days followed by the swelling of right side of the face.During this time, the patient felt hot and had very hard lumps(implant site mass) all over her face that were really painful.The patient also felt sick to her stomach (abdominal discomfort), nausea (nausea) and was not wanting to eat anything (decreased appetite).The patient informed that after each swelling attack, as the swelling went down, the other symptoms also gradually went away.On (b)(6) 2021, the patient underwent an unspecified surgery in which knuckle from pinky finger was removed because it was calcified from osteoarthritis.The patient's most recent swelling attack was (b)(6) 2021 (thursday night), when her face started to swell up and this swelling became worse by (b)(6) 2021 (friday).The patient felt really bad and very tired this past time starting (b)(6) 2021 and described this attack as the reddest, most painful, and most swollen her face has ever been.On (b)(6) 2021 (saturday), the patient's face was flushed and her upper body felt hot.The swelling on (b)(6) 2021 was to both the right and left nlfs and marionette lines at the same time.On (b)(6) 2021 (sunday), the patient woke up with her eye swollen shut, her face was swollen, and the left side of her mouth and left eye were droopy.The left lip was pulled down because the lump was so swollen.This was the third time patient had the droopiness.By (b)(6) 2021 (tuesday), the droopiness was gone.It was reported that the lumps that formed in this past swelling attack ((b)(6)2021) were not going away.The lumps on the marionette lines are gravitating downwards.The lumps on the left side have gotten progressively worse and are more visible.The patient still had two lumps in the left marionette line and a flattened strip on the left nlf.The patient had one lump further down from injection site that gets to be a size of a quarter when it inflames (implant site inflammation) up and when the right side erupts.The patient described the lump as being very hard and red when it inflamed.The lumps were painful up until 15-jun-2021 (tuesday) and tender to touch.Outcome at the time of the report: swelling was recovered/resolved.Little pink/red was recovered/resolved.Hard was recovered/resolved.Painful was not recovered/not resolved.Flu like symptoms was not recovered/not resolved.Tired was recovered/resolved.Achy neck, shoulders and sometimes lower back would hurt was recovered/resolved.Eyes would get a little bloodshot was recovered/resolved.Flushed was recovered/resolved.Headache was recovered/resolved.Eyes were puffy was recovered/resolved.Felt hot/warm was recovered/resolved.Lumps was not recovered/not resolved.Sick to her stomach was recovered/resolved.Eye pain was recovered/resolved.Eyelids were red was recovered/resolved.Rash that looked like dermatitis contact was recovered/resolved.Inflames was recovered/resolved migraines was recovered/resolved.Uncomfortable was recovered/resolved.Nausea was recovered/resolved.Feeling generally unwell was recovered/resolved.Upper body felt hot was recovered/resolved.Not wanting to eat anything was recovered/resolved.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 12162963
• MDR Text Key: 268478973
• Report Number: 9710154-2021-00050
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR