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

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.

• Brand Name: RESTYLANE KYSSE
• Type of Device: IMPLANT, 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 Key: 10315071
• MDR Text Key: 208130249
• Report Number: 9710154-2020-00063
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140029/S021
• Number of Events Reported: 1
• 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 Received: 07/23/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2022
• Device Lot Number: 17994
• 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 Received: 07/23/2020
• 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