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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED AB RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 19269
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Hematoma (1884); Obstruction/Occlusion (2422); Pallor (2468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/16/2021
Event Type  Injury  
Manufacturer Narrative
Company comment: the serious event of vascular occlusion and the non-serious events of haematoma, bruising and pallor at implant site were considered expected and possibly related to the treatment. The likely root cause include intravascular filler injection leading to vascular occlusion and its manifestations. Restylane defyne was used off label. The case meets the criteria for expedited reporting to the regulatory authorities. Product note: 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 17-nov-2021 by another health care professional which refers to a (b)(6) female patient. The patient's medical history included hormonal acne. Concomitant medications included spironolactone [spironolactone] for hormonal acne, allegra [fexofenadine hydrochloride] and adderall [amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate]. The patient had no known allergies. The patient had previously received treatments with unspecified filler to chin and botox. The patient had no vaccines or dental procedures in the last 6 to 12 months or any illness in the month prior to treatment. On (b)(6) 2021, the patient received treatment with 0. 1 ml restylane defyne (lot 19269) to lips (unknown injection technique and needle type). The restylane defyne was injected to lips (off label use of device). On (b)(6) 2021, the patient started to develop a hematoma (implant site haematoma). The hcp assessed it as an occlusion (vascular occlusion) and injected three vials of hylenex [vorhyaluronidase alfa] into the area. After leaving it for 30 minutes, the patient was having bruising (implant site bruising) outside the lip moving to the nasolabial fold with paleness (implant site pallor) to the lip. On (b)(6) 2021, the symptoms resolved. On 19-nov-2021, the medical director was to follow up with the patient. Outcome at the time of the report: hematoma was recovered/resolved. Bruising was recovered/resolved. Paleness was recovered/resolved. Occlusion was recovered/resolved. Restylane defyne was injected to lips was recovered/resolved.
 
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Brand NameRESTYLANE DEFYNE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED AB
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer (Section G)
GALDERMA Q-MED AB
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer Contact
randy russell
14501 n. freeway
fort worth, TX 76177
MDR Report Key12976973
MDR Text Key285330254
Report Number9710154-2021-00077
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P140029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number19269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/10/2021 Patient Sequence Number: 1
Treatment
ADDERALL; ALLEGRA; SPIRONOLACTONE
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