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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Ischemia (1942); Necrosis (1971); Pain (1994); Skin Discoloration (2074); Swelling (2091); Ulcer (2274); Pallor (2468); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious, expected events of embolism, implant site ischaemia, implant site necrosis, and the non-serious, expected events of pain, swelling, pallor, discolouration, vesicles and ulcer at the implant site were considered expected and possibly related to the treatment.Serious criteria included the need for medical intervention to prevent permanent damage.Potential contributory factor include injection technique.This case meets the criteria of seriousness and causality for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive action will be initiated.The events are expected.It is stated in the warning section in the ifu for the restylane range of products that the product should not be injected intravascularly.As for other injectable medical devices inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis.Manufacturer narrative: the suspect product was not specified.Lot number was not provided.(b)(4).

Event Description

Case reference (b)(4) is a literature report received on 03-jan-2018.Wang et al., vascular complications after chin augmentation using.Aesthetic plast surg 2017; doi: 10.1007/s00266-017-1036-3.A (b)(6) woman underwent ha augmentation of the mentum at another cosmetic institution.The ha volume was 1 ml.The technical details of the filling procedure are unknown.During the injection procedure, the patient felt soreness and swelling in the filling area, and the anterior region of her chin became pale.However, she was told that the symptoms were common and would soon disappear.On the next morning, the previously blanching region showed a red-black discoloration with formation of several blisters.She immediately returned to that cosmetic institution.Hyaluronidase (brand name and dosage unknown) was injected into her chin, and hot compresses and a recombinant human epidermal growth factor gel were applied.The skin of the mentum did not recover from the discoloration and a superficial ulcer gradually developed.The superficial ulcer developed in the central area of the chin 3 days after the young female patient underwent ha augmentation of the mentum, despite the administration of hyaluronidase on postoperative day 2.In this case, the skin necrosis less likely resulted from a direct occlusion of a certain artery (inferior labial artery, mental artery, submental artery, or their branches).It is more likely to be a consequence of massive microcirculatory embolism and/or external compression of the skin microvasculature.The patient felt pain and experienced immediate blanching of the chin.Digital compression examination revealed slow capillary refill in the pale area.All these observations indicated that microcirculatory filler embolism had occurred.The affected site developed necrosis because the symptoms were ignored and not managed promptly.Treatment with hyaluronidase injection in the ischemic area was performed on the next day.This delay may have had the certain effect of hindering the prevention of ischemia development, thus ultimately resulting in a superficial ulcer.

• Brand Name: UNKNOWN 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 Contact: lisa benaise ; seminariegatan 21; uppsala, SE-75-2 28 ; SW SE-752 28
• MDR Report Key: 7209475
• MDR Text Key: 97884635
• Report Number: 9710154-2018-00011
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Date Report Sent to FDA: 01/22/2018
• Distributor Facility Aware Date: 01/18/2018
• Event Location: Other
• Date Report to Manufacturer: 01/03/2018
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/22/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR