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 Headache (1880); Occlusion (1984); Pain (1994); Swelling (2091); Discomfort (2330); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious, expected event of vascular occlusion, the non-serious, unexpected event of discomfort, and the non-serious, expected events of pain, oral hypoaesthesia, headache, swollen tongue, tongue discolouration and oral paraesthesia were considered possibly related to the treatment.The non-serious event of tongue atrophy was considered to be secondary to the vascular event and therefore 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 with the exception of discomfort.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 an unspecified ha filler.Lot number was not reported.(b)(4).

Event Description

Case (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) healthy woman underwent ha augmentation of the chin for better proportion of her lower face.The information about ha was unclear, and the details of the injection procedure are unknown.During the injection, she suddenly felt pain followed by numbness in the right side of her tongue.In addition, she developed a headache and felt discomfort in the nuchal region.Head magnetic resonance imaging was immediately performed to detect any acute cerebral infarction or hematencephalon.The mri scanning showed no acute cerebrovascular event.Ultrasonography examination of the cervical vessels revealed no significant stenosis.The right side of the tongue became swollen and dull-red in color 2 h after ha injection.The pain and numbness persisted.Intravascular intervention radiation angiography was performed 6 h after the ha injection.The angiography result showed that the distal section of the deep lingual artery was absent, and the anterior part of the right tongue had delayed visualization and low-density radiocontrast.Multipoint injection of hyaluronidase (100 u dissolved in 1 ml normal saline) was performed on the right side of the tongue.Owing to the lack of reference for intravascular administration and the concern about significant adverse effects on vital organs, intra-arterial application of hyaluronidase was not conducted.The symptoms of swelling and discoloration persisted for two days.From the third day, the affected side of the tongue became mildly atrophic.The pain disappeared on postoperative day five.The paresthesia persisted until postoperative day nine, when the patient was lost to follow-up.In this case, the signs and symptoms (pain, numbness, discoloration, and swelling) of the tongue indicated the possibility that a sudden vascular occlusion had occurred.The interventional angiography examination, which showed no development of the distal section of the deep lingual artery and a low-density area in the anterior part of the right tongue, further confirmed the diagnosis.

• 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: 7209478
• MDR Text Key: 97888622
• Report Number: 9710154-2018-00012
• 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: 42 YR