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

Lot Number 16744

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

Patient Problems Bruise/Contusion (1754); Occlusion (1984); Pain (1994); Skin Discoloration (2074); Discomfort (2330); Pallor (2468); No Code Available (3191)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 27-sep-2019 by a physician which refers to a (b)(6) caucasian female patient. No information about medical history or history of allergies has been provided. Concomitant treatments included dysport injection, 50 units to glabellar area on (b)(6) 2019 and also on (b)(6) 2019. The patient had previously received treatment with unspecified filler and toxins. On (b)(6) 2019, the patient received treatment with 1 ml restylane silk (lot 16744) to glabellar area 0. 05 ml (off label use), rest into perioral area with cannula and unknown technique. Same day, on (b)(6) 2019, the patient experienced blanching (implant site pallor) around the artery in forehead and then it went away. The patient also had discoloration (dusky, reddish)(implant site discolouration) to glabellar area. The hcp rubbed the area and it appeared to improve. The physician thought there was a possible occlusion (vascular occlusion). 3 days later, on (b)(6) 2019, the patient experienced pain/tenderness (implant site pain), pressure(injection site discomfort) and looked a little dusky. Then patient developed pustules (implant site pustules). The patient also experienced bruising (implant site bruising) to glabella and around the eyes and also had a few papules (implant site papules) just above the injection site following the line of the artery. The hcp treated patient with hylenex [hyaluronidase] 600 units and gave aspirin [acetylsalicylic acid] 325 mg and told her to continue taking aspirin 80 mg daily. The pain and pressure have subsided but she still has some tenderness around the hairline even after physician gave 600 units of hylenex. The hcp also treated her with an ozone bag too. It was reported that physician was finding out, whether patient needs more hylanex since she still has tenderness around that artery. The patient also said it was feeling better that day compared to before, although it looks worse than before. Outcome at the time of the report: blanching was recovered/resolved. Discoloration (dusky, reddish) was unknown. Pain/tenderness was not recovered/not resolved. Pressure was recovered/resolved. Pustules was unknown. Possible occlusion was unknown. Bruising was not recovered/not resolved. Papules was not recovered/not resolved. Restylane silk injected to glabellar area was recovered/resolved.

• Brand Name: RESTYLANE SILK
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 9203485
• MDR Text Key: 162866528
• Report Number: 1000118068-2019-00012
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2021
• Device Lot Number: 16744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Distributor Facility Aware Date: 12/11/2019
• Event Location: Other
• Date Report to Manufacturer: 12/11/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 10/17/2019 Patient Sequence Number: 1