MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE REFYNE; IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)

Lot Number UNKNOWN

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

Patient Problems Bruise/Contusion (1754); Skin Discoloration (2074); Skin Erosion (2075); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of inflammation at implant site, and the non-serious events of irritation and bruising at implant site were considered expected and possibly related to the treatments.The serious event of epidermolysis and the non-serious events of livedo reticularis and skin erosion were considered unexpected and possibly related to the treatments.Serious criteria included the need for multiple medical interventions, including hyaluronidase, antibiotics and acetylsalicylic acid (asa) to prevent permanent damage as larger vascular damage was reportedly prevented.Potential root causes for the reported events include the user error of possible intravascular injection and the known risks of intravascular injection, inflammation secondary to procedural trauma, and infection due to microbial contamination associated with the treatment procedure.The potential root causes for the later onset epidermolysis includes progressing inflammation, ischemia, vasculitis and necrosis and potential aggravation of the events by an adverse drug reaction to asa given the medical history of underlying nsaid allergy.The platelet rich plasma was likely provided to reverse the effects of the asa platelet depletion, and this plasma infusion along with trofolastin cream administration likely enhanced wound healing.Potential contributory factors include suboptimal injection technique, propensity for fragile underlying skin in the infraorbital region and vasculitis from vascular events or potential asa allergy.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Engineering evaluation (capa comment): 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.Lot number was not reported.A batch record review could not be performed.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 29-sep-2020 by a physician which refers to a (b)(6) female patient.The patient had no significant medical history.The patient had ibuprofen allergy.The patient was not on any concomitant medications.No information about previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with restylane lyft and restylane refyne to infra-orbital area for wrinkles (unknown amount, lot number, injection technique and needle type).Same day, on (b)(6) 2020, the patient experienced irritation(implant site irritation) of the infraorbital area, some local inflammation(implant site inflammation), dubious painless livedo(livedo reticularis).No local pain.The post-inflammation was partly due to bruising(implant site bruising).Treatment for the adverse events included hyaluronidase [hyaluronidase] 400 iu every 8-12 hours, 500 unspecified units of cloxacin [cloxacillin sodium], aas [acetylsalicylic acid] 100-200 mg/day and silkeses.On (b)(6) 2020 the patient received a cycle of prp (platelet-rich-plasma) and trofolastin cream.On (b)(6) 2020, the patient was controlled.The patient was being treated for epidermolysis(epidermolysis) and erosion(skin erosion).Possible deep vascular involvement was stopped.There was no nasal, ocular or angular affectation.On (b)(6) 2020, the patient improved a lot.Outcome at the time of the report: irritation was recovering/resolving.Local inflammation was recovering/resolving.Livedo was recovering/resolving.Bruising was recovering/resolving.Epidermolysis was recovering/resolving.Erosion was recovering/resolving.Tracking list: v.0 initial.V.1 fu received on 11-nov-2020 from the same reporter: additional events of epidermolysis and erosion were added.Corrective treatment and outcome of the events were updated.

Manufacturer Narrative

Pharmacovigilance comment: the serious event of inflammation at implant site, and the non-serious events of irritation and bruising at implant site were considered expected and possibly related to the treatments.The serious event of epidermolysis and the non-serious events of livedo reticularis and skin erosion were considered unexpected and possibly related to the treatments.Serious criteria included the need for multiple medical interventions, including hyaluronidase, antibiotics and acetylsalicylic acid (asa) to prevent permanent damage as larger vascular damage was reportedly prevented.Potential root causes for the reported events include the user error of possible intravascular injection and the known risks of intravascular injection, inflammation secondary to procedural trauma, and infection due to microbial contamination associated with the treatment procedure.The potential root causes for the later onset epidermolysis includes progressing inflammation, ischemia, vasculitis and necrosis and potential aggravation of the events by an adverse drug reaction to asa given the medical history of underlying nsaid allergy.The platelet rich plasma was likely provided to reverse the effects of the asa platelet depletion, and this plasma infusion along with trofolastin cream administration likely enhanced wound healing.Potential contributory factors include suboptimal injection technique, propensity for fragile underlying skin in the infraorbital region and vasculitis from vascular events or potential asa allergy.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Engineering evaluation (capa comment): 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.A batch record review could not be performed.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 29-sep-2020 by a physician which refers to a 52-year-old female patient.The patient had no significant medical history.The patient had ibuprofen allergy.The patient was not on any concomitant medications.No information about previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with restylane lyft and restylane refyne to infra-orbital area for wrinkles (unknown amount, lot number, injection technique and needle type).Same day, on (b)(6) 2020, the patient experienced irritation(implant site irritation) of the infraorbital area, some local inflammation(implant site inflammation), dubious painless livedo(livedo reticularis).No local pain.The post-inflammation was partly due to bruising(implant site bruising).Treatment for the adverse events included hyaluronidase [hyaluronidase] 400 iu every 8-12 hours, 500 unspecified units of cloxacin [cloxacillin sodium], aas [acetylsalicylic acid] 100-200 mg/day and silkeses.On (b)(6) 2020 the patient received a cycle of prp (platelet-rich-plasma) and trofolastin cream.On (b)(6) 2020, the patient was controlled.The patient was being treated for epidermolysis(epidermolysis) and erosion(skin erosion).Possible deep vascular involvement was stopped.There was no nasal, ocular or angular affectation.On (b)(6) 2020, the patient improved a lot.As per follow up information received on 07-dec-2020, the patient already had a 90 percent recovery.There was still some epidermis to be recovered.Outcome at the time of the report: irritation was recovering/resolving.Local inflammation was recovering/resolving.Livedo was recovering/resolving.Bruising was recovering/resolving.Epidermolysis was recovering/resolving.Erosion was recovering/resolving.Tracking list: v.0 initial.V.1 fu received on 11-nov-2020 from the same reporter: additional events of epidermolysis and erosion were added.Corrective treatment and outcome of the events were updated.V.2 fu received on 07-dec-2020 from the same reporter: the patient already had a 90 percent recovery.There was still some epidermis to be recovered.

• Brand Name: RESTYLANE REFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10984352
• MDR Text Key: 220891860
• Report Number: 9710154-2020-00097
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR