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

Lot Number 18396

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

Patient Problems Anaphylactic Shock (1703); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of anaphylactic shock was considered expected and possibly related to the treatment.Serious criteria included life-threatening and the need for urgent medical care, which included treatment with epinephrine.Potential root causes include hypersensitivity reactions to the product or the dental block.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturer narrative: lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-dec-2020 by an other health professional which refers to an adult female patient.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date, the patient received treatment with restylane kysse (unknown amount, lot number, injection technique and needle type) to unknown location.The patient had dental block by hcp.6 minutes later, on an unknown date, the patient went into anaphylactic shock(anaphylactic shock).On an unknown date, the patient received treatment with epi [epinephrine] 0.3 (units unspecified) by hcp but event did not resolve.The hcp administered another 0.3 of epi and event resolved.Outcome at the time of the report: anaphylactic shock was recovered/resolved.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of anaphylactic shock and non-serious unexpected events of throat tightness, dyspnoea, dysphagia were considered possibly related to the treatments.Serious criteria included life-threatening and the need for urgent medical care, which included treatment with epinephrine, benadryl and solumedrol.Potential root causes include hypersensitivity reactions to the product or the dental block.The case meets the criteria for expedited reporting to the 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 indicate a possible involvement of the product.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-dec-2020 by an other health professional which refers to 59-year-old female patient.The patient's medical history included allergy to grass.The patient had anaphylactic shock in allergist office in response to grass.The patient had previously received treatment with juvederm ultra plus to cheeks in (b)(6) 2019.The patient had not experienced any illness in the month prior to treatment in the last 6 to 12 months.The patient had covid-19 in (b)(6) 2020.On an unknown date in (b)(6) 2020, the patient received flu vaccine.On (b)(6) 2020, the patient received treatment with 0.5 ml restylane kysse (lot 18394) to vertical lip lines using unknown needle type with tenting injection technique.The patient also had dental block.Approximately 10 minutes later injection began, on (b)(6) 2020, the patient started complaining of tightening of throat(throat tightness), dysphagia(dysphagia) and shortness of breath (sob)(dyspnoea).The patient experienced anaphylactic shock(anaphylactic shock) involving mouth, tongue and throat.The patient received treatment with epinephrine [epinephrine] 1:1000, 0.3 ml and benadryl [diphenhydramine hydrochloride] 50mg on (b)(6) 2020, resulted in cessation of symptoms.The patient went to emergency room for treatment with solumedrol [methylprednisolone sodium succinate] and patient was completely resolved.Outcome at the time of the report: anaphylactic shock was recovered/resolved.Tightening of throat was recovered/resolved.Dysphagia was recovered/resolved.Shortness of breath (sob) was recovered/resolved.Tracking list: v.0 initial; v.1 fu received on 09-feb-2021 from the same reporter: events (throat tightness, dyspnoea, dysphagia).Patient demographics, medical history, past treatment, restylane kysse implant date, location, volume, injection technique, lot number, event anaphylactic shock event locations, start, stop date, severity, reporter causality and corrective treatment details were updated.

• Brand Name: RESTYLANE KYSSE
• 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: 11067417
• MDR Text Key: 223591876
• Report Number: 1000118068-2020-00047
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 18396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2021
• Distributor Facility Aware Date: 02/09/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLU VACCINE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR