• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GALDERMA Q-MED RESTYLANE REFYNE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 16815-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Erythema (1840); Granuloma (1876); Pain (1994); Pallor (2468); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The reported lot number was valid. Pharmacovigilance comment: the serious event of embolism arterial was considered expected and possibly related to the treatment. Serious criteria include the need for intervention to prevent permanent damage. The non-serious events of pallor, pain, livedo reticularis, granuloma skin and erythema at the implant site were considered expected and possibly related to the treatment. Potential etiologies of the events include injection of filler into blood vessel leading to embolism and its manifestations of pallor, pain, and livedo reticularis. Potential etiologies of the subsequent granulomas and erythema include inflammatory and infectious complications of the ischemic event. Potential contributory factors for late onset findings include persistence of the embolus since only led light therapy was reported as corrective therapy. Pulsed light might be used to remove discoloration associated with bruising or post-inflammatory hyperpigmentation. The case meets the criteria for expedited reporting to the regulatory authorities. 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.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 14-nov-2019 by a physician which refers to a (b)(6) female patient. No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On (b)(6) 2019, the patient received treatment with 1 ml of restylane volyme (lot s2191070005) for filling of tear trough with unknown needle and injection technique. On (b)(6) 2019, the patient received treatment with 1 ml of restylane refyne (lot 16815-1) for filling of nasolabial folds with unknown needle and injection technique. An unknown time later, on an unknown date in 2019, the patient experienced embolization(embolism arterial) of the facial and nasal artery, bleaching(pallor), very intense pain(pain) hemifacially and livedo(livedo reticularis) of the upper left lip, nose and left cheekbone. No eye complications were reported. As corrective treatment, the patient underwent 5 sessions of led but the treatment stopped. After one month, on an unknown date in (b)(6) 2019, the patient experienced erythema(implant site erythema) and granulomas(granuloma skin) on the left side of nose area. Outcome at the time of the report: embolization was unknown. Very intense pain was unknown. Livedo was unknown. Bleaching was unknown. Erythema was unknown. Granulomas was unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTYLANE REFYNE
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 Key9458430
MDR Text Key185930799
Report Number9710154-2019-00109
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P140029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number16815-1
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 Received11/14/2019
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: 12/12/2019 Patient Sequence Number: 1
-
-