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

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Tissue Damage (2104); Discomfort (2330); Skin Inflammation (2443)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The serious events of purulent discharge, infection at implant site and skin wound and the non-serious events of implant site inflammation and injection site discomfort were considered expected and possibly related to the treatment. Serious criteria include the need for medical interventions including antibiotics, corticosteroid, wound care and drainage. Potential contributory factor include inadequate aseptic precautions leading to infection. The case meets the criteria for expedited reporting to the regulatory authorities. Corrective action: 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.

Event Description

Case reference number no (b)(4) is a spontaneous report sent on 25-feb-2020 by a female consumer, which refers to herself (unknown age). No information about medical history, concomitant medications, history of allergies or previous filler treatments has been provided. On an unknown date, the patient received treatment with restylane nos to an unknown location (unknown amount, lot number, injection technique and needle type). On (b)(6) 2020, the patient skin burst by itself and pus/fluid/matter/filler came out (purulent discharge). This provided a great relief to the patient because the pressure in skin (injection site discomfort) for the past two weeks had been extremely intense and peaked during the previous night. On (b)(6) 2020, the patient woke up and discovered it had built up again during the night. The patient went to see a general practitioner who sent her to the emergency room. The physician at the emergency room opened, rinsed and emptied to the best of his ability as instructed by a plastic surgeon, but the encapsulated inflammation (implant site inflammation) under the chin remained. According to the patient, she was given several different contra-instructions as what should be done. On (b)(6) 2020, patient was told that a drainage/plastic tube should be inserted to keep the wound open so that it could heal. On (b)(6) 2020, a bacterial test was performed at the emergency room, no other information was received. On (b)(6) 2020, the patient visited another emergency room, and the wound was rinsed. The patient received another instruction, and after they had emptied what was in the chin. The patient was told that they saw no reason to place anything there again. The last instruction given was that the patient herself should rinse the wound with saline solution [sodium chloride] twice a day, and wound should be uncovered as much of the time as possible. The patient had done so, and the wound had started to heal quickly, but then she felt that the inflammation was increasing. The patient reported that it had not stopped to leaking/dripping wound (skin wound) fluid from the chin as long as the skin had an opening in it. It had leaked/dripped from the wound continuously from the (b)(6) 2020 and had slowed down somewhat as the opening had started to close. At the day of the reports leaking/dripping was still ongoing. The patient had received the following medications: dicloxacillin orion [dicloxacillin sodium monohydrate], 500 mg, 4 times daily from (b)(6) 2020 to (b)(6) 2020 and apocillin [phenoxymethylpenicillin potassium], 1 gram tablets, 4 times daily from (b)(6) 2020. The patient also took prednisolone [prednisolone] for 3 days after recommendation of a physician from (b)(6) 2020 to (b)(6) 2020 to relieve some pressure. The pressure had gotten a little easier with predisolone and she had then stopped taking predisolone. Outcome at the time of the report: skin burst by itself and pus/fluid/matter/filler came out was unknown. Leaking/dripping wound was not recovered/not resolved. Encapsulated inflammation was not recovered/not resolved. Pressure in skin was recovering/resolving.

• Brand Name: RESTYLANE LYFT
• 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 AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, tx
• MDR Report Key: 9883972
• MDR Text Key: 196936093
• Report Number: 9710154-2020-00043
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2020,04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2020
• Distributor Facility Aware Date: 02/25/2020
• Event Location: No Information
• Date Report to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/18/2020
• 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: Unkown

Patient Treatment Data

Date Received: 03/26/2020 Patient Sequence Number: 1