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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Blurred Vision (2137); Visual Impairment (2138); Dizziness (2194); Discomfort (2330); Loss of consciousness (2418)
Event Date 04/03/2018
Event Type  Injury  
Event Description
Case (b)(4) is a spontaneous report sent on 27-jul-2018 by a consumer which refers to a female (b)(6). The patient's denied any significant medical history and reported no known allergies. Previous filler treatments were not reported. On (b)(6) 2018, the patient received treatment with an unknown amount of restylane refyne (lot unknown) to the tear troughs and an unknown amount of restylane defyne (lot unknown) to the cheeks with unknown needle and technique. The patient also received treatment with botox [botox] in the glabellar region on the same day ((b)(6) 2018). On the same day, (b)(6) 2018, the patient experienced flush(flushing) around the left eye and light glare, vision affected(glare). On an unspecified date in (b)(6) 2018, the patient experienced pressure behind eye(ocular discomfort) and was light headed, dizziness(dizziness). One month later, in (b)(6) 2018, the patient experienced blackouts (loss of consciousness). Treatment for the adverse event included injection of hyaluronidase [hyaluronidase] on a total of 3 dates: (b)(6) 2018 and 2 other unspecified dates. The patient also sought treatment at an emergency room (er) on two separate occasions, but the details of the treatment was not reported. The patient was directed to follow up with an otolaryngologist and neurologist for additional workup. Outcome at the time of the report: flush was not recovered/not resolved. Light glare, vision affected was not recovered/not resolved. Pressure behind eye was not recovered/not resolved. Light headed, dizziness was not recovered/not resolved. Blackouts was not recovered/not resolved.
 
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Brand NameRESTYLANE DEFYNE
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 Key7783437
MDR Text Key117136821
Report Number1000118068-2018-00026
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
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?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/14/2018
Distributor Facility Aware Date07/27/2018
Event Location No Information
Date Report to Manufacturer07/27/2018
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: 08/14/2018 Patient Sequence Number: 1
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