MAUDE Adverse Event Report: Q-MED RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 19267

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

Patient Problems Abscess (1690); Cellulitis (1768); Cyst(s) (1800); Purulent Discharge (1812); Discomfort (2330); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. The reported lot number was valid and verified the reported product. The information in this case does not indicate a non-conforming product or malfunction. The performed investigations are therefore considered adequate and no additional investigations will be conducted. Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations. Company comment: the serious expected events of cellulitis and swelling at implant site were considered possibly related to the treatments. Serious criteria include the need for medical intervention and hospitalization to prevent permanent damage. The potential root cause include treatment procedure. The case meets the criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 27-jan-2022 by an other health professional concerning a (b)(6) female patient. The patient was not pregnant. The patient had no known allergies. No information about medical history or previous filler treatments has been provided. Concomitant treatments included oral protonix [omeprazole]. On (b)(6) 2022, the patient received treatment with 1 ml restylane silk (lot 17319) to upper lip, 2 ml restylane lyft with lidocaine (lot 19673 and 19107),1 ml to each side of cheek and 1 ml restylane defyne (lot 19267) to left nasolabial fold with unknown injection technique and needle type. The patient also received juvederm brand filler to right nasolabial fold on the same day. In (b)(6) 2022, the patient experienced an extensive/massive reaction; facial cellulitis (implant site cellulitis) and facial swelling (implant site swelling). On (b)(6) 2022, the patient reported the events to the hcp. On (b)(6) 2022, the patient received first dose of iv daptomycin [daptomycin] antibiotics and received subsequent iv daptomycin doses from (b)(6) 2022 to present. On (b)(6) 2022, the patient was hospitalized at a medical center. On (b)(6) 2022, the patient will be discharged for surgical incision and drainage. Outcome at the time of the report: cellulitis was not recovered/not resolved/ongoing. Swelling was not recovered/not resolved/ongoing.

• Brand Name: RESTYLANE DEFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 13546775
• MDR Text Key: 290069725
• Report Number: 9710154-2022-00008
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 19267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: 02/16/2022 Patient Sequence Number: 1

Treatment

JUVEDERM; JUVEDERM; PROTONIX [OMEPRAZOLE]; PROTONIX [OMEPRAZOLE]; RESTYLANE DEFYNE; RESTYLANE LYFT WITH LIDOCAINE; RESTYLANE LYFT WITH LIDOCAINE; RESTYLANE SILK