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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED RESTYLANE KYSSE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 18393
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious event of vascular occlusion was considered expected and possibly related to the treatment. Serious criteria include the need for medical intervention with multiple hyaluronidase treatments to prevent permanent damage. The likely root cause include intravascular filler injection leading to vascular occlusion. 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. 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 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-mar-2021 by an other health professional which refers to an adult patient of unknown gender. 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. Unknown time later, on an unknown date, the patient experienced vascular occlusion(vascular occlusion). On an unknown date, the patient was treated with multiple flushes of hylenex [hyaluronidase]. Outcome at the time of the report: vascular occlusion was unknown.
 
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Brand NameRESTYLANE KYSSE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer Contact
randy russell
14501 north freeway
fort worth, TX 76177
MDR Report Key11578472
MDR Text Key243903524
Report Number9710154-2021-00018
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P140029/S021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Lot Number18393
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
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 Unkown

Patient Treatment Data
Date Received: 03/26/2021 Patient Sequence Number: 1
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