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

Lot Number 19059, 19056

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

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Complaint comment: the serious event of dyspnoea which is expected for restylane lyft lidocaine and unexpected for restylane contour was considered possibly related to both treatments.The serious events of throat tightness and dysphagia were considered unexpected and possibly related to both treatments.The non-serious expected event of swelling at implant site and the non-serious unexpected event of panic attack were considered possibly related to both treatments.Serious criteria included the need for urgent medical intervention to prevent life threatening condition or permanent damage.The potential root cause include the patient's hypersensitivity reaction to the products.The unexpected events are secondary events to expected hypersentivity reactions that can occur with the treatments.The panic attack is potentially due to anxiety associated with the treatment procedure.Potential contributory factor included concomitant medication or the patient's predisposition to allergic reactions.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: 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 numbers were valid and verified the reported product.No adverse events had been reported on the lot numbers until 15-jun-2021.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 14-sep-2021 by an other health professional concerning a (b)(6) female patient.Additional information was received on the same day from same reporter.The patient's medical history included high blood pressure, eczema, allergic to penicillin, sulfa and codeine and covid-19 in (b)(6) 2020.The patient had previously received treatment with restylane lyft in 2018.Concomitant medications included omeprazole [omeprazole] 20 mg, lisinopril [lisinopril] and betamethasone dipropionate [betamethasone dipropionate] ointment.The patient had no vaccines in the past 6-12 months or any illness the month prior to her injection session.On (b)(6) 2021, the patient received treatment with 2 ml restylane contour (lot 19059 and 19056), 1 ml per zygomatic arch and 0.5 ml restylane lyft with lidocaine (lot 19192), 0.25 ml per zygomatic arch with unknown injection technique and needle type.On (b)(6) 2021, around 8:30 pm, the patient felt that throat was closing/tightness to throat (throat tightness) and patient thought she might be having a panic attack (panic attack).The patient had a drink and went to bed.On (b)(6) 2021, the patient felt her throat was closing again, she could not eat/trouble swallowing (dysphagia) and had trouble breathing (dyspnoea).The patient visited the er on the same day and was treated with a unspecified steroid shot.Also underwent a ct scan of neck and throat, which was negative.The patient also experienced swelling (implant site swelling) at zygomatic arches, which was resolved on its own the same day.On (b)(6) 2021, the tightness to her throat came back.On (b)(6) 2021, the patient went back to the er, where she was treated with iv steroids.The physician at the hospital thought it might be related to her lisinopril and advised her to stop taking the lisinopril.On (b)(6) 2021, the patient started taking prednisone [prednisone] 40mg every 6 hours.The patient still had tightness to her throat/feeling her throat was closing, trouble swallowing and trouble breathing.Outcome at the time of the report: throat was closing/tightness to throat was not recovered/not resolved/ongoing.Could not eat/trouble swallowing was not recovered/not resolved/ongoing.Trouble breathing was not recovered/not resolved/ongoing.Swelling was recovered/resolved.

• Brand Name: RESTYLANE CONTOUR
• 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: 12632382
• MDR Text Key: 276393330
• Report Number: 1000118068-2021-00030
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Lot Number: 19059, 19056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Distributor Facility Aware Date: 09/14/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BETAMETHASONE DIPROPIONATE; LISINOPRIL; OMEPRAZOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR