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

Lot Number UNKNOWN

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

Patient Problems Embolism (1829); Erythema (1840); Skin Discoloration (2074)

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial literature report.Pharmacovigilance comments: the serious event of embolism and the non-serious events of skin discolouration and erythema were considered expected and possibly related to the treatment with an unspecified hyaluronic acid filler.Serious criteria included hospitalization and the need for multiple medical interventions with hyaluronidase, iv dexamethasone, high doses of unspecified antibiotics and antibiotic soaked gauze pads.Potential etiologies for the event of embolism include vascular compromise due to vascular occlusion or compression and potential contributory factors include injection technique.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.Manufacturing narrative: lot number was not reported.(b)(4).

Event Description

Case reference number (b)(4) is a literature report detected on 24-oct-2018 by med info.This case (referred as patient nr.2 in table 1 in the article) refers to a (b)(6) female patient that received treatment with an unspecified ha filler to the nasolabial folds.In addition, this case is also linked with eight other cases that "is" also included in the same article (linked case: (b)(4)).Citation of the article: zhang et al.Local cooling as a step of treatment for tissue ischemia caused by hyaluronic acid injection-induced embolism: a report of 9 cases.Plast reconstr surg glob open 2018; 8: 6 (8).Patient specific information: table 1.Patient cases of local cooling treatment of tissue ischemia caused by hyaluronic acid injection-induced embolism.Patient number 2 - gender: female - age: (b)(6) - injection site: nasolabial folds - injection dosage: na - admission time (after injection): 2 d - local cooling outcome duration: 1wk; no scarring.General information: from 2014 till date, a total of 9 patients were administered the antibiotic saline gauze local cooling as a step for treatment of tissue ischemic syndrome caused by hyaluronic acid injection-induced embolism (table 1).All 9 patients were female, with age ranging from 20 to 35 years.Injection sites included the nasolabial folds (5 patients), alar groove (1 patient), glabellar lines (1 patient), and labial tubercle (1 patient), forehead augmentation (1 patient), and the injected volume of hyaluronic acid was 0.4-3 ml.The timing of postembolism hyaluronidase injection ranged between 5 minutes and 3 days postoperatively.Symptoms of patients noted during consultation included local persistent severe pain, while signs included dark purple patches and mottling of the skin in localized areas, which displays clinical manifestations includes severe pain, dark purple patches, and mottling of the skin in localized areas in the early stage of tissue ischemia caused by hyaluronic acid injection-induced embolism.The most serious sign observed in patients was black scabs or blisters at the center of the lesion, with a history of scattered purulent spots for about 3 days.Each admitted patient was first injected with hyaluronidase at a concentration of 150-300 u/ml at sites filled with hyaluronic acid and areas showing abnormal skin color.After injection, the affected sites were massaged for 30 minutes, followed by local cooling using an antibiotic saline-soaked gauze pad at each site.The method of local cooling was as follows: antibiotic saline was refrigerated at 4°c for more than 2 hours.Then sterile gauze pads were soaked in the chilled antibiotic saline and applied at areas of skin showing dark purple discoloration.Gauze pads were replaced every 30 minutes, with a 30-minute rest period between 2 consecutive local coolings; alternatively, local cooling was reapplied only when the patient experienced localized pain.The patient was observed once per half an hour by nurse and twice a day by doctors.Local cooling is used at least 5 days for every patient who is suffered from ha induced embolism in our unit.Systemic medication administered to patients included high doses of antibiotics and an intravenous infusion of dexamethasone at a dose of 5-10 mg/d over 3 consecutive days.In all cases, local symptoms were considerably relieved within 3 days of treatment.All patients experienced residual redness in local skin areas after completion of treatment, which persisted for a maximum duration of 3 months.Clinically, local cooling did reduce the early symptoms of localized pain and facilitated effective treatment of the 9 patients with hyaluronic acid injection-induced local embolism.

• Brand Name: UNSPECIFIED FILLER (RESTYLANE)
• 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: 8041278
• MDR Text Key: 126228034
• Report Number: 9710154-2018-00070
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR