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

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.

• Brand Name: UNSPECIFIED HA FILLER
• Type of Device: IMPLANT, 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 Key: 7638348
• MDR Text Key: 112409985
• Report Number: 9710154-2018-00040
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR