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

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Granuloma (1876); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of granuloma skin and the non-serious events of erythema and swelling at implant site and induration were considered possibly related to the treatment.Serious criteria include the need for medical intervention to prevent permanent damage.Potential etiologies infection and saladenitis or inflammatory nodules secondary to procedural trauma.The bilateral neck cords indicate potential extension of the infection or inflammation beyond the implant site.Potential contributory factors include injection technique and dental hygiene.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 02-sep-2020 by a physician which refers to a (b)(6)-year-old female patient.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date in (b)(6) 2020, the patient received treatment with restylane to nasolabial folds, jawline (unknown lot number, injection technique and needle type).Unknown time later, on an unknown date in (b)(6) 2020, the patient had experienced granulomatous lesion (granuloma skin) to the right and left chin area that were the size of golf balls.Unknown time later, on an unknown date in (b)(6) 2020, the patient experienced cutaneous cords(induration) that look like red (implant site mass) ropes and swollen along neck.On an unknown date in 2020, as a treatment, patient was injected with hyaluronidase [hyaluronidase], kenalog [triamcinolone acetonide] and 5-fu [fluorouracil].The patient was also prescribed prednisone [prednisone] and steroids.It was reported that the lesions and the cutaneous cords along her neck had not yet resolved and the cords were still red and swollen.Outcome at the time of the report: granulomatous lesion was not recovered/not resolved.Cutaneous cords was not recovered/not resolved.Red was not recovered/not resolved.Swollen was not recovered/not resolved.

• Brand Name: RESTYLANE
• 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
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 10544079
• MDR Text Key: 212727996
• Report Number: 9710154-2020-00074
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR