MAUDE Adverse Event Report: GALDERMA Q-MED AB DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of infection at injection site and the non-serious events of swelling and pain at the injection site were considered expected and possibly related to the treatment.Serious criteria included the need for medical and surgical intervention to prevent permanent damage and hospitalization.Potential root cause for the events include injection procedure associated with inadequate aseptic technique.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.Manufacturer 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 will be performed.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.

Event Description

This spontaneous report ((b)(4)) was received on 21-jun-2021 from a pharmacist concerning a (b)(6) years old unk patient.Additional information received on 13-jul-2021.No information about medical history, concomitant medication, history of allergies or previous similar treatments has been provided.On an unknown date, the patient received treatment with 3 ml of durolane to knee (unknown lot number, injection technique and needle type).On (b)(6) 2021, after receiving treatment the patient reported that they were hospitalized as durolane caused an infection on knee (injection site infection) that required surgery.An infection that occurred due to medication (as reported).The patient developed painful (injection site pain) swelling (injection site swelling).The patient was treated with cortisone (cortisone), which did not help.Progressively, it got worse.The doctor confirmed that the patient had a very serious infection.The patient had an emergency surgery on knee on an unknown date in 2021.Additionally, the patient had a month of intravenous antibiotics.The patient was still undergoing blood work to reassure the infection was gone.The event was still ongoing.Corrective treatments included the patient received at the time of report, outcome of event: injection site pain was unknown, injection site swelling was unknown, injection site infection was not recovered/not resolved/ongoing.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• 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 north freeway; fort worth, TX 76177
• MDR Report Key: 12196454
• MDR Text Key: 262444078
• Report Number: 9710154-2021-00051
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR