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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED AB RESTYLANE KYSSE IMPLANT, DERMAL, FOR AESTHETIC USE (LMH) Back to Search Results
Lot Number 17994
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling (2091); Skin Inflammation (2443); Pallor (2468); Vascular System (Circulation), Impaired (2572); No Code Available (3191)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious adverse event of vascular occlusion was considered expected and possibly related to the treatment. Serious criteria include the need for medical intervention. The non-serious adverse events of implant site swelling, pain, induration, bruising, and pallor, dryness at injection site, and skin tightness were considered expected and possibly related to the treatment. Potential contributory factor may have included an intravascular filler injection leading to vascular occlusion and subsequent ischaemic manifestations. 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. Manufacturing narrative: the reported lot number was valid.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 08-jul-2020 by a health care professional and which refers to a (b)(6)-year-old female patient. The patient has no reported medical history or allergies. The patient does not routinely use any medications or products. The patient had previously received treatment with juvederm. On (b)(6) 2020, the patient received treatment with 0. 5 ml restylane kysse (lot 17994) to lips (unknown injection technique and needle type). Same day, on (b)(6) 2020, the patient experienced swelling(implant site swelling), pain(implant site pain), blanching(implant site pallor), firmness(implant site induration), tightness(skin tightness) and dryness(injection site dryness) to lips. The patient also had a purple bruise(implant site bruising) that was changing colors, from her cupid's bow to her nostrils. The hcp reported that the patient had developed a late-onset vascular occlusion(vascular occlusion). The patient was treated with ice and hylenex [hyaluronidase] by the hcp, but the adverse events have not yet resolved. The hcp stated that the color temporarily began returning to normal, but the blanching came back shortly after. Outcome at the time of the report: late-onset vascular occlusion was not recovered/not resolved. Swelling was not recovered/not resolved. Pain was not recovered/not resolved. Bruise was not recovered/not resolved. Blanching was not recovered/not resolved. Firmness was not recovered/not resolved. Tightness was not recovered/not resolved. Dryness was not recovered/not resolved.
 
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Brand NameRESTYLANE KYSSE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE (LMH)
Manufacturer (Section D)
GALDERMA Q-MED AB
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer (Section G)
GALDERMA Q-MED AB
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer Contact
randy russell
14501 n. freeway
fort worth, tx 
9615146
MDR Report Key10315071
MDR Text Key208130249
Report Number9710154-2020-00063
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Lot Number17994
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
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: 07/23/2020 Patient Sequence Number: 1
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