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

Lot Number 18828

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

Patient Problems Erythema (1840); Headache (1880); Hemorrhage/Bleeding (1888); Skin Discoloration (2074); Obstruction/Occlusion (2422); Sensitivity of Teeth (2427); Pallor (2468); Paresthesia (4421); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious expected events of vascular compression, nerve compression, the non-serious expected events of paraesthesia, pain, haemorrhage at implant site, headache, gingival erythema, gingival discolouration, tooth discolouration, hyperaesthesia teeth, pallor, poor peripheral circulation, toothache and the unexpected events of rhinorrhea, paranasal sinus discomfort were considered possibly related to the treatment.Seriousness criteria included the need for multiple medical interventions to prevent the permanent damage.The potential root cause include injection of filler in the vicinity of blood vessel or nerve leading to vascular or nerve compression and their manifestations in association with off label use.Potential contributory factor include injection technique.The restylane defyne was used off label.The case meets the criteria for expedited reporting to the regulatory authorities.Product 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.The reported lot number was valid and verified the reported product.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.No corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number us (b)(4) is a spontaneous report sent on 18-may-2022 by a physician assistant which refers to a 55-year-old female patient.Additional information was received on 25-may-2022 from same reporter.No information about medical history, concomitant medication or history of allergies has been provided.The patient had previously received treatment with restylane defyne to lips.On 15-apr-2022, the patient received treatment with 1 ml of restylane defyne (lot 18828), 0.2 ml to depressor septi nasi muscle (under nose), 0.2 ml to the supra tip midline deep nose, and remainder of the syringe contents 0.6 ml was injected into the lips (unknown injection technique and needle type).The restylane defyne was injected to under nose and lips (off label use of device).When hcp injected under the depressor septi nasi, the patient felt pain/tenderness (implant site pain) during injection, and had a lingering sensitivity (implant site paraesthesia) at that nerve.The patient stayed at the office until she was feeling better, and the hcp gave her prednisone [prednisone] 20 mg, which she took at home that night.The hcp had instructed the patient to give an update of how she was feeling.The patient called the hcp and informed that she had a headache/frontal headache (headache) and her nose was running more (rhinorrhoea) than usual.Also the patient had sensitivity at the base of her septum.The hcp asked the patient to come to the office but she declined and replied that she did not need more injections.On 16-apr-2022 in the morning, the hcp called the patient and she still had sensitivity and nose running.The patient continued to decline corrective treatment/removal of the filler.On 17-apr-2022, the hcp called the patient and she was feeling much better.The hcp requested the patient to call if anything was wrong.On 22-apr-2022, the patient came to the hcp office for visit.The patient's gums were hyperemic (gingival erythema).There was a red patch/bluish (gingival discolouration) with a little white area (pallor), which looked like a cold sore she was prone too.The hcp prescribed 1 gram valtrex [valaciclovir hydrochloride] twice per day for what looked like a cold sore and augmentin [amoxicillin, clavulanic acid] 875mg twice per day for the sinus pressure (paranasal sinus discomfort)/frontal headache.There was no sign of necrosis.The patient's pulse was great.The patient also informed she was getting a little bit of nosebleeds (implant site haemorrhage), which was not reported to the hcp until 22-apr-2022.The hcp had examined her nose and there was a slight blood-tinged area.She pressed on the septi area and some tenderness was noted.The patient was given pro-nox and hcp treated area with hylenex [vorhyaluronidase alfa] between the nostrils-columnella where she complained of sensitivity.The hcp was preparing to treat the depressor septi area with the remaining hylenex but the patient refused more hylenex doses at that time and she said it was too traumatic.The hcp explained to her if they did not remove the filler it could result in severe necrosis.The hcp spoke to the patient that night over the phone and she thought the augmentin 875 mg was helping and was feeling much better.The patient had also just started using the valtrex 1 gram.There was still a little patch of redness on gum.On 23-apr-2022, the dentist had examined the patient.The hcp was not sure of the outcome of this visit.According to the dentist, they could wait with the root canal.The patient was warned not to air travel.The patient called hcp stating that her other tooth was turning gray-right-lateral and she was experiencing sensitivity.The hcp examined the patient that night and her other tooth was not turning gray.Based on another physician opinion, her antibiotic was switched from augmentin to clindamycin [clindamycin] 150 mg four times per day to protect against bacteria.On 24-apr-2022, the patient traveled in plane against hcp advice.The rn whom patient had met called the reporting hcp and reported that the patient's tooth lateral next to central incisor was gray.There was no pain.On 28-apr-2022, the hcp contacted the medspa owner for advice on next course of action but the owner recommended a consult with a dentist, past filler-trainer for allergan.The dentist had examined the patient in her office and recommended hcp to refer her to the maxillofacial surgeon.There were two teeth involved.Since the patient had sensation, it was possible that the nerve was not dead.There was no rush to perform root canal yet, they could save that tooth and put a veneer over it.On 29-apr-2022, the patient visited hcp office and stated that she had a consultation with a dentist to cauterize her nose.The patient's front right central incisor tooth was turning gray (tooth discolouration) and there was sensitivity in that tooth (hyperaesthesia teeth) whenever she ate.She also had trouble biting down because of pain in teeth (toothache).The hcp informed that she was going to lose her tooth if they did not treat her.The hcp called the owner of medspa where the patient was working and informed them about the need to treat the patient with hylenex immediately.The hcp called the rn closest to the office who came in to assist.The patient was put on pro-nox lying in bed with the help of a registered nurse and treated her with 1000 mg of hylenex which was 9-10 bottles under the depressor septi muscle, gums, the columnar area (base of nose).Her pulse was great.According to the hcp, the superior labial was not compromised.Inter alveolar artery was fine.She thought maxillary nerve got compressed/nerve root compression (nerve compression) underneath or might be cutting off the blood supply (poor peripheral circulation) to the interior alveolar nerve, which might be the reason why the tooth was gray.There was a little bit of blood coming from her nose and thereafter flooded the area.According to the dentist whom reporting hcp contacted, there was a possibility that the tooth nerve was not dead.The hcp saw an improvement of the hyperemic area on her gums from all the hylenex injections.On 29-apr-2022 or 06-may-2022, the patient visited the hcp at office.The hcp was feeling pressure around her nose with qtip and pressure when around the columnella artery (base of nose).The hcp treated the patient with more hylenex 150mg in that area.The patient reported she did not feel any pressure or soreness when she pressed the area and she was feeling better.The patient still had nose bleeds and will consult an ent.The dentist wanted the patient to see an endodontist to check the quality of the nerve route.On 19-may-2022, the reporting hcp had a follow up appointment scheduled with the patient.According to reporting the hcp, since the filler was injected under the depressor septi nasi muscle to lift the tip, she suspected vascular compromise/ compressed (vascular compression) versus nerve root compression (because link trigeminal, the v2 branch maxillary goes around and underneath the depressor septi).The maxillary nerve also connects to the anterior alveolar nerve of the central incisor tooth.The area might be compressed, causing loss of blood supply to tooth, which would explain the cold sore-looking whiteness which was experienced in a day-or-two after the injection.As per hcp, if columellar artery was compressed, which goes to the superior labial artery in the lip, then also the lip would be necrosed.Outcome at the time of the report: vascular compromise/compressed was not recovered/not resolved/ongoing.Maxillary nerve got compressed/nerve root compression was not recovered/not resolved/ongoing.Pain/tenderness was not recovered/not resolved/ongoing.Lingering sensitivity was not recovered/not resolved/ongoing.Headache/frontal headache was not recovered/not resolved/ongoing.Nose was running more was not recovered/not resolved/ongoing.Gums were hyperemic was recovering/resolving.Red patch/bluish was not recovered/not resolved/ongoing.A little white area was not recovered/not resolved/ongoing.Sinus pressure was not recovered/not resolved/ongoing.Nosebleeds was not recovered/not resolved/ongoing.Front right central incisor tooth was turning gray was not recovered/not resolved/ongoing.Sensitivity in that tooth was not recovered/not resolved/ongoing.Pain in teeth was not recovered/not resolved/ongoing.Cutting off the blood supply was not recovered/not resolved/ongoing.Restylane defyne was injected to under nose and lips was recovered/resolved.

• Brand Name: RESTYLANE DEFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 14638421
• MDR Text Key: 294850211
• Report Number: 9710154-2022-00033
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Lot Number: 18828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female