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

Lot Number S2202870003

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

Patient Problem Angioedema (4536)

Event Date 01/19/2022

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 31-jan-2022 by a physician, which refers to a (b)(6) year old female patient.No information about medical history, history of allergies or concomitant medication has been provided.The patient had previously received treatment with unspecified filler product from (b)(4).In (b)(6) 2021 the patient had received last dose of an unspecified covid-19 vaccine.On (b)(6) 2022 the patient received treatment with 0.5 ml restylane kysse (lot s2202870003) to lips and perioral area to perform lips contour and technique of perioral parallels bars using co-packed needle with unknown injection technique.On (b)(6) 2022 the patient experienced moderate angioedema (angioedema) during product application in lips and further stated that patient did not evolve to anaphylactic shock.The patient was treated with intravenous hydrocortisone [hydrocortisone], intramuscular adrenaline [epinephrine], general support and care with vital signs.The patient used unspecified antihistamines for 15 days and prednisone [prednisone] for 5 days.Also applied cold compress at region.The patient was not hospitalized, however, she stayed for observation at physician's office at all day of procedure and was accompanied for 7 days.No laboratory test was performed.After three days on (b)(6) 2022 the patient experienced total regression of angioedema in effect of the adequate treatment.The reporter had assessed the causality as possible.Outcome at the time of the report: angioedema was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 02-feb-2022 from the same reporter: case upgraded to serious.Patient vaccine history, suspect device implant location, volume, needle type, expiry date, event onset date, location, severity, outcome, reporter causality and corrective treatment details were updated.

Manufacturer Narrative

Restylane kysse-routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.Until 15-jun-2021, no events had been reported for the lot s2202870003.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.Capa comment: restylane kysse-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Company comment: the serious event of angioedema was considered expected and possibly related to the treatment.Serious criteria included the need for urgent medical intervention to prevent permanent damage or life threatening condition.The likely root cause include patient's hypersensitivity to the product.The case meets the criteria for expedited reporting to the regulatory authorities.

• Brand Name: RESTYLANE KYSSE
• 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: 13545561
• MDR Text Key: 287007908
• Report Number: 9710154-2022-00004
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P140029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

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: 09/30/2022
• Device Lot Number: S2202870003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/16/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White