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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Pain (1994); Skin Discoloration (2074); Numbness (2415); Pallor (2468)
Event Type  Injury  
Manufacturer Narrative
Manufacturer narrative: lot number was not reported. Capa comment: 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. Pharmacovigilance comment: the serious expected event of embolism arterial was considered possibly related to the treatment. Serious criteria include the need for multiple medical interventions to prevent permanent damage or disability. The non-serious expected events of pallor, hypoaesthesia, pain and discolouration at implant site were considered possibly related to the treatment. Potential contributory factor include injecting filler into the blood vessel, leading to emboli, vascular occlusion and consequences. The case meets the criteria for expedited reporting to the regulatory authorities.
 
Event Description
Case reference number (b)(4) is a literature report sent on 18-dec-2019 by an other health professional which refers to a (b)(6)-year-old female patient. This case was identified from the literature article xue-li li, yun-fei li, hua-juan wu, li-na d, chun-yang z, hong c. Early signal and prevention analysis of vascular embolism caused by hyaluronic acid injection of nasolabial fold. Clinical data: a (b)(6)-year-old female patient received bone surface injection of hyaluronic acid restylane ii (restylane, q-medab, sweden) 0. 5 ml to apertura piriformis of the right nasolabial fold using a sharp needle, and 3 min later the right nasal alar skin became white (fingernail-sized) and graniphyric, and the patient felt local numbness sensation with unobvious pain. The injection was discontinued immediately, and 30 min later there were lilac graniphyric changes in the right upper lip arterial region upwards along the nasal external artery, without abnormality in vision. Analysis of anatomical mechanism and etiology for vascular embolism: the case 1 received injection of hyaluronic acid to the nasal root. Based on the skin injury and graniphyric skin pallor followed by cyanosed appearance after injection, it was considered that the hyaluronic acid emboli mainly occluded the blood supply the area of right facial artery and external nasal artery anastomotic branches with extensive embolic area. It reminds us that injection of stuffings to nasal base should strictly follow the principle of it is better less than more, close clinging to periosteum. Emergent countermeasures for embolism: as to the patient with vascular embolism symptoms at nasolabial fold injection site, the injection was discontinued immediately when they experienced vascular embolism symptoms including whitening and lilac color changes on skin in hyaluronic acid injection related region. Comprehensive treatment was applied, and rescue measures were taken. The specific measures included injecting hyaluronidase: it often contains 1500 u hyaluronidase and can be diluted in normal saline 1 ml to prepare 1500 u/ml solution. Collect 0. 1 ml of the solution (containing hyaluronidase 150 u) can be dissolved by a ratio of 1:1. Inject hyaluronidase to the corresponding sites, commonly 0. 05-0. 1 ml at each site will make it effective. The injection velocity is better slow and the layer is better deeper, and moderate massage is beneficial to the drug diffusion. As to case 1, the injection site was nasolabial fold, thus hyaluronidase multi-point injection (150-600 u at each site, with total volume up to 1500 u) should be given immediately at injection site and local vascular embolism sites. Local hot compress: warm gauzes (at 30[?]-50[?]) should be externally applied immediately at injection sites and vascular embolism sites so as to dilate local vessels, increase local skin blood supply and reduce tissue ischemia and anoxia. Using vasodilators: take sublingual administration of nitroglycerin tablets (0. 5 mg); low molecular dextran 500ml ivgtt, for consecutive 1 week. Oxygen therapy: give oxygen aspiration at 3-5 l/min immediately, followed by hyperbaric oxygen therapy every day in the subsequent 2 weeks, so as to promote the local oxygen content in ischemic tissues, reduce tissue ischemic re-perfusion injury and improve local microcirculation and nutritional state, so as to accelerate tissue recovery and the dissolution and absorption of necrotic tissues[2]. Preventing infection: externally apply 0. 1% benzalkonium chloride solution and mupirocin ointment; give acyclovir tablets 0. 4mg tid for preventive treatment for patients with past history of herpes simplex. Preventing pigmentation: externally apply mucopolysaccharide polysulfate cream on local skin for consecutive 2 weeks since the mucopolysaccharide polysulfate can prevent the superficial thrombosis, promote tissue absorption, prevent the development of local inflammation, accelerate the absorption of hematoma, and promote the regeneration of normal connective tissues. Conclusion: case received above active treatments after the occurrence of embolism. As to case 1, the brown-purple pigmented plaques remained on the skin in vascular embolism lasted for 3 weeks after rescue treatment, which was gradually improved after 2 doses of intensive pulse light therapy.
 
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Brand NameRESTYLANE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 north freeway
fort worth, TX 76177
8175615353
MDR Report Key9555490
MDR Text Key189345238
Report Number9710154-2020-00001
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P040024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/18/2019
Was Device Evaluated by Manufacturer? No
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: 01/06/2020 Patient Sequence Number: 1
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