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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA Q-MED UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Occlusion (1984); Discomfort (2330); Pallor (2468)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious event of vascular occlusion was considered expected and possibly related to the treatment. Serious criteria include the need for multiple medical interventions with hyaluronidase, topical nitroglycerin and aspirin to prevent permanent damage. Potential contributory factors include injection technique. The non-serious events of erythema, pallor and discomfort were considered expected and possibly related to the treatment. The events are likely secondary to the event of vascular occlusion. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation: 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. Manufacturer narrative: lot number was not reported. (b)(4).
 
Event Description
Case reference number (b)(4) is a literature report which was detected on 19-jun-2018 by med info. (b)(6), vascular occlusion after hyaluronic acid filler injection. Clin pract cases emerg med 2018; 2(2):167-168. A (b)(6)-year-old female presented to the emergency department (ed) with progressively worsening forehead erythema and discomfort after receiving an injection of hyaluronic acid filler into the glabella at a medical spa the previous day. On arrival to the ed, she was afebrile with normal vital signs. Physical examination revealed blanchable erythema extending from the mid-forehead to the nasal bridge in a linear distribution with early retiform appearance on the nasal sidewalls (image). The patient denied visual symptoms, and ophthalmic examination was normal. She was diagnosed with vascular occlusion as a result of hyaluronic acid filler injection. She was treated with an intradermal injection of 490u hyaluronidase (2. 45ml of 200u/ml) administered in multiple small injections around the linear erythema. After the injection, a single dose of 2% nitroglycerin paste was applied to the skin for five minutes. She was discharged home on a two-week course of aspirin 325mg daily. The patient had outpatient follow-up one day and four days after her initial presentation. She had complete resolution of symptoms. Image. Linear erythema of the forehead with retiform appearance of the nasal bridge in a woman after hyaluronic acid filler injection.
 
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Brand NameUNSPECIFIED HA FILLER
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 Key7638348
MDR Text Key112409985
Report Number9710154-2018-00040
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/26/2018 Patient Sequence Number: 1
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