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

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Pv comment: the serious event of swelling at implant site and the non-serious events of erythema and induration at implant site were considered expected and possibly related to the treatments.Serious criteria include the need of multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure and associated inadequate aseptic technique.Potential contributory factor includes unspecified dental procedure.The case meets the criteria for expedited reporting to the regulatory authorities.Manufacture narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.A follow up on the lot number will be performed in order to be able to request a batch record review.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician which refers to an (b)(6) old male patient.The case became valid on (b)(6) 2021 based on additional information received from the same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2021, the patient received treatment with 1 ml of restylane lyft, 0.5 ml to each mandibular angle (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received treatment with 4ml of restylane refyne, 1ml to each mandibular profile and mandibular angle projection and 1 syringe to each malar area (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received treatment with 2 syringes of restylane vital, 1 syringe to each mandibular line in the subdermal plane (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received second treatment with 5 syringes of restylane refyne, 0.5 ml to each nasolabial groove, 1 syringe to each corner of the mouth and chin crease and 1 syringe to each preauricular area (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient went to a dentist for an unspecified reason.12 days after treatment with restylane lyft and restylane refyne and 6 days after treatment with restylane vital, on (b)(6) 2021, the patient noticed the appearance of swelling(implant site swelling) in the mandibular area.14 days after treatment with restylane lyft and restylane refyne and 8 days after treatment with restylane vital, on (b)(6) 2021, the patient experienced redness(implant site erythema) and progressive areas of hardening(implant site induration) especially at the level of the right mandibular and pre-jowl angle.On (b)(6) 2021, the patient began oral cortisone therapy with bentelan [betamethasone sodium phosphate] 4 mg per day with a graduated dosage up to 1 mg on (b)(6) 2021 and also antibiotic therapy with augmentin [amoxicillin sodium;clavulanate potassium] 2 tablets per day for 7 days.After initial improvement, the swelling and redness reappeared on (b)(6) 2021 in the locations indicated and also in the left malar region.The patient also experienced worsening of hardening in the mandibular areas and progressively similar reactions had also appeared on the right nasolabial groove.On an unknown date in 2021, the patient started receiving antibiotic therapy with intramuscular rocefin [ceftriaxone sodium] 1 per day for 5 days.The patient also received hyaluronidas [hyaluronidase] infiltrations in the areas involved between (b)(6) 2021 and the day of the report with clinical improvement.At the time of the report, the patient was being treated with bentelan 1 mg.A follow up with the physician was scheduled on the day of the report.Outcome at the time of the report: swelling was recovering/resolving.Redness was recovering/resolving.Hardening was recovering/resolving.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician which refers to an 82-year-old male patient.The case became valid on (b)(6) 2021 based on additional information received from the same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2021, the patient received treatment with 1 ml of restylane lyft, 0.5 ml to each mandibular angle (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received treatment with 4ml of restylane refyne, 1ml to each mandibular profile and mandibular angle projection and 1 syringe to each malar area (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received treatment with 2 syringes of restylane vital, 1 syringe to each mandibular line in the subdermal plane (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient received second treatment with 5 syringes of restylane refyne, 0.5 ml to each nasolabial groove, 1 syringe to each corner of the mouth and chin crease and 1 syringe to each preauricular area (unknown lot number, injection technique and needle type) for an unknown indication.On (b)(6) 2021, the patient went to a dentist for an unspecified reason.12 days after treatment with restylane lyft and restylane refyne and 6 days after treatment with restylane vital, on (b)(6) 2021, the patient noticed the appearance of swelling(implant site swelling) in the mandibular area.14 days after treatment with restylane lyft and restylane refyne and 8 days after treatment with restylane vital, on (b)(6) 2021, the patient experienced redness(implant site erythema) and progressive areas of hardening(implant site induration) especially at the level of the right mandibular and pre-jowl angle.On (b)(6) 2021, the patient began oral cortisone therapy with bentelan [betamethasone sodium phosphate] 4 mg per day with a graduated dosage up to 1 mg on (b)(6) 2021 and also antibiotic therapy with augmentin [amoxicillin sodium;clavulanate potassium] 2 tablets per day for 7 days.After initial improvement, the swelling and redness reappeared on (b)(6) 2021 in the locations indicated and also in the left malar region.The patient also experienced worsening of hardening in the mandibular areas and progressively similar reactions had also appeared on the right nasolabial groove.On an unknown date in 2021, the patient started receiving antibiotic therapy with intramuscular rocefin [ceftriaxone sodium] 1 per day for 5 days.The patient also received hyaluronidas [hyaluronidase] infiltrations in the areas involved between (b)(6) 2021 and the day of the report with clinical improvement.At the time of the report, the patient was being treated with bentelan 1 mg.A follow up with the physician was scheduled on the day of the report.Outcome at the time of the report: swelling was recovering/resolving.Redness was recovering/resolving.Hardening was recovering/resolving.Tracking list: follow up was performed but without success.A final mir was compiled to be submitted to the health authorities.

Manufacturer Narrative

Pv comment: the serious event of swelling at implant site and the non-serious events of erythema and induration at implant site were considered expected and possibly related to the treatments.Serious criteria include the need of multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure and associated inadequate aseptic technique.Potential contributory factor includes unspecified dental procedure.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacture narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.A follow up on the lot number will be performed in order to be able to request a batch record review.

• Brand Name: RESTYLANE REFYNE
• 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: 12103463
• MDR Text Key: 267864747
• Report Number: 9710154-2021-00047
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESTYLANE LYFT.; RESTYLANE LYFT.; RESTYLANE SKINBOOSTER VITAL.; RESTYLANE SKINBOOSTER VITAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR