MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE LYFT LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 17719-1

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

Patient Problems Abscess (1690); Erythema (1840); Unspecified Infection (1930); Swelling (2091); Swelling/ Edema (4577)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of infection and abscess at implant site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage or scarring.The non-serious expected events of erythema and swelling at implant site were considered possibly related to the treatment.Potential contributory factors for infection at implant site include improper aseptic precautions, which might have caused swelling, erythema and abscess at implant site.The case meets the seriousness 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: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 10-jul-2020 by a physician which refers to a (b)(6)-year-old male patient.Additional information was received on 15-jul-2020 from the secretary/operation coordinator on behalf of a physician.No information about medical history, history of allergies or previous filler treatments has been provided.The patient does not take any other products or medicines.On (b)(6) 2020, the patient received treatment with 0.3 ml restylane lyft lidocaine (lot 17719-1) to the bridge of the nose (unknown injection technique and needle type).3 days later, on (b)(6) 2020, the patient had experienced infection (implant site infection) with swelling (implant site swelling), redness (implant site erythema) and abscess (implant site abscess) on the nose.The causality to the treatment was listed as possible.On (b)(6) 2020, the patient received treatment with antibiotic dalacin [clindamycin hydrochloride] tablet, 300 mg thrice daily, for the bridge of the nose, for 10 days.The patient also received betapred [betamethasone sodium phosphate] for 3 days the antibiotic and the betapred had reversed the symptoms.As per information received on 11-aug-2020 from lso, reporter had assessed the case serious by checking yes for the question was the intervention or hospitalisation required to prevent a life threatening condition, permanent impairment of a body function or permanent damage to a body structure.Hence case upgraded as serious.This was erroneously missed in earlier version.Outcome at the time of the report: infection was recovered/resolved.Abscess was recovered/resolved.Swelling was recovered/resolved.Redness was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 10-jul-2020 from the same reporter: version opened for correction.Case upgraded to serious.Events infection and abscess updated to serious.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by a physician which refers to a 43-year-old male patient.Additional information was received on 15-jul-2020 from the secretary/operation coordinator on behalf of a physician.No information about medical history, history of allergies or previous filler treatments has been provided.The patient does not take any other products or medicines.On 17-jun-2020, the patient received treatment with 0.3 ml restylane lyft lidocaine (lot 17719-1) to the bridge of the nose (unknown injection technique and needle type).3 days later, on 20-jun-2020, the patient had experienced infection (implant site infection) with swelling (implant site swelling), redness (implant site erythema) and abscess (implant site abscess) on the nose.The causality to the treatment was listed as possible.On 22-jun-2020, the patient received treatment with antibiotic dalacin [clindamycin hydrochloride] tablet, 300 mg thrice daily, for the bridge of the nose, for 10 days.The patient also received betapred [betamethasone sodium phosphate] for 3 days the antibiotic and the betapred had reversed the symptoms.As per information received on 11-aug-2020 from lso, reporter had assessed the case serious by checking yes for the question was the intervention or hospitalisation required to prevent a life threatening condition, permanent impairment of a body function or permanent damage to a body structure.Hence case upgraded as serious.This was erroneously missed in earlier version.Outcome at the time of the report: infection was recovered/resolved.Abscess was recovered/resolved.Swelling was recovered/resolved.Redness was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 10-jul-2020 from the same reporter: version opened for correction.Case upgraded to serious.Events infection and abscess updated to serious.V.2 version opened to add brr results and to submit final mir.No new information available from reporter.

Manufacturer Narrative

Pharmacovigilance comment: the serious events of implant site nodule and encapsulation reaction were considered expected and possibly related to both treatments.Serious criteria includes the need for multiple medical interventions with hyaluronidase, steroids and antibiotics.The non-serious event of implant site swelling was considered expected and possibly related to restylane defyne treatment but unrelated to restylane skinbooster vital lidocaine treatments since the event was confined to the lips where the restylane defyne was implanted.The non-serious event of psoriasis was considered unexpected and unrelated to both treatments.Potential alternative etiologies for psoriasis include triggers such as environmental and lifestyle factors.Potential contributory factors for the lumps, encapsulation and psoriasis include an underlying systemic inflammatory disorder.The case meets the 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: no potential quality issues have been identified in the manufacturing process of the specified batch 17568-1.The batch is manufactured and released according to galderma quality management system.

• Brand Name: RESTYLANE LYFT LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10448800
• MDR Text Key: 208132229
• Report Number: 9710154-2020-00069
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P040024/S073
• 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: 10/05/2020

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: Health Professional
• Device Lot Number: 17719-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR