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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLADERMA Q-MED RESTYLANE-L IMPLANT, DERMAL, FOR AESTHETIC USE

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GLADERMA Q-MED RESTYLANE-L IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 18037
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Neuralgia (4413); Subcutaneous Nodule (4548); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/08/2021
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious expected event of vascular occlusion and non-serious expected event of induration, swelling, bruising, discolouration at implant site and non-serious unexpected events of neuralgia and poor peripheral circulation were considered possibly related to the treatment. Serious criteria include the need for multiple medical interventions. The likely root cause for the events include intravascular filler injection leading to vascular occlusionand its manifestations. 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. Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. The reported lot number was valid and verified the reported product. 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 04-feb-2021 by an other health professional which refers to a (b)(6) -year-old female patient. Additional information was received on 05-feb-2021 from same reporter. No information about medical history has been provided. The patient had no known allergies. The patient had microdermabrasion and chemical peels in the past. The patient had previously received treatment with restylane-l on (b)(6)-2020, restylane lyft with lidocaine on (b)(6) 2020, botox and dysport. Concomitant treatments included spironolactone [spironolactone], vitamin d [vitamin d nos], zinc [zinc], duloxetine [duloxetine] and birth control [contraceptives]. The patient had not yet received the covid vaccine. She had no dental procedures or vaccines in the past 6-12 month and any illnesses in the month prior to her session. On (b)(6) 2021, the patient received treatment with 1 ml restylane-l (lot 18037), 0. 4 ml to upper lip and 0. 3 ml bilaterally to pyriform apertures with unknown injection technique and needle type. In the same session, the patient also received treatment with dysport [dysport] to 30 units to the glabella, 20 units to the forehead, 15 units to the crow's feet bilaterally, and 15 units to the chin and polydioxanone (pdo) threads to her cheeks. Same day, on (b)(6) 2021, the patient experienced swelling(implant site swelling) and bruising (implant site bruising) which was resolved before or by (b)(6) 2021. It was also reported that patient also had vascular occlusion(vascular occlusion) while injecting restylane-l into the lip. It was firm like cement/hardness(implant site induration). 12 days later, on (b)(6) 2021, patient reported that she had sharp, shooting and throbbing pain/nerve pain(neuralgia) to her right upper lip that radiated to her right cheek, which our nurse described as nerve pain, which she thought had resolved the next day. On (b)(6) 2021, the patient reported a sharp pain between her nose and lip, extreme bruising to her right upper lip so that a nickel-sized area of the right upper lip was purple(implant site discolouration). She said the nerve pain came back and had worsened. The patient also had lack of circulation/sluggish blood flow(poor peripheral circulation), swelling, and her right upper lip was painful and thick. The patient stated that she feels like her lip is going to split open when she smiles. The upper lip was like cement and it was 2-3 times normal size. The nerve pain resolved by (b)(6) 2021 but there was very mild tenderness to the areas where blood flow is sluggish. The hcp treated patient initially with ibuprofen [ibuprofen] and then she was injected with about 2 vials of hylenex [hyaluronidase] per visit (around 12 vials of hylenex in total). On (b)(6), 2 vials of hylenex injected in the morning and another 2 vials that evening. On (b)(6), she was seen about 2-3 times and each time she received about 2 vials of hylenex. On (b)(6), 1. 7 vials hylenex injected when she came into the office; another 2 vials of hylenex given to her at her home. Hcp stated that the the hylenex had resolved the lack of circulation when she saw the patient on (b)(6) 2021, but the patient still has sluggish blood flow to certain areas like the vermillion border, columellas and subnasal area. On (b)(6), 2. 3 vials hylenex injected. Massaged the lip. The sluggish blood flow was to the right and left upper lip and right nlf. The patient's right upper lip still has bruising although it has lightened up and the swelling to the right upper lip was still there but was better. The lip was no longer hard as cement but the areas of hardness are still there and she still has tenderness to the areas where blood flow was sluggish. Outcome at the time of the report: vascular occlusion was not recovered/not resolved. Swelling was recovering/resolving. Bruising was not recovered/not resolved. Firm like cement/hardness was not recovered/not resolved. Sharp, shooting and throbbing pain/nerve pain was not recovered/not resolved. Lack of circulation/sluggish blood flow was not recovered/not resolved. Purple was not recovered/not resolved.
 
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Brand NameRESTYLANE-L
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GLADERMA Q-MED
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key11372178
MDR Text Key242052560
Report Number1000118068-2021-00005
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 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number18037
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Distributor Facility Aware Date02/11/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/11/2021
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: 02/24/2021 Patient Sequence Number: 1
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