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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED RESTYLANE SILK IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameRESTYLANE SILK
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
MDR Report Key9203485
MDR Text Key162866528
Report Number1000118068-2019-00012
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Lot Number16744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2020
Distributor Facility Aware Date12/11/2019
Event Location Other
Date Report to Manufacturer12/11/2019
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
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