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

Lot Number 21368

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

Patient Problems Rash (2033); Blister (4537)

Event Date 10/14/2023

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 31-oct-2023 by a (b)(6) via sales representative, which refers to a 46-year-old female patient.Additional information was received on 31-oct-2023, 07-nov-2023 and 28-nov-2023 from the same reporter.No information about medical history, concomitant medication, or history of allergies has been provided.The patient had previously received treatment with durolane twice.On (b)(6) 2023, the patient received third treatment with durolane (lot 21368) to left knee joint (unknown amount, injection technique and needle type) by the physician.The injection was not performed under ultrasound guidance.On 14-oct-2023, the following day after the treatment, the patient experienced a red and purple (injection site erythema) rash (injection site rash) accompanied by pain (injection site pain) with the rash on the medial side of the left knee, which was contralateral to the injection site (injection performed lateral side of left knee).On an unknown date in (b)(6) 2023, the patient went to the emergency room.The patient has been treated with unspecified steroid as well as benadryl [diphenhydramine hydrochloride].On an unknown date, the patient had a ct scan scheduled.On 07-nov-2023, additional information was reported from the reporting physician.The patient had developed a new symptom of blisters (injection site vesicles), but overall, the physician felt the patient's condition was improving.On 28-nov-2023, additional information was reported from the reporting physician.The patient had improved significantly at 3-4 post injection.No cultures were taken, and no medical intervention was needed.Patient was given antibiotics and steroids.Physician could not provide any additional patient information.Outcome at the time of the report: red and purple was recovering/resolving.Rash was recovering/resolving.Pain was recovering/resolving.Blisters was recovering/resolving.

Manufacturer Narrative

Company comment: the serious expected event of rash at injection site and the unexpected event of vesicles at injection site, and the non-serious expected events of erythema and pain at injection site were considered possibly related to the treatment.Based on patient pictures and correspondence with reporter, the importer's clinical specialist suspected nicolau syndrome and skin necrosis.The manufacturer assess the seriousness criteria as medically significant events of rash and vesicles at injection site, which if left untreated could lead to skin necrosis and permanent damage.Potential root cause is the injection procedure, and a more specific cause cannot be established based on the available information.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.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.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE752 28; SW SE75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE752 28; SW SE75228
• Manufacturer Contact: randy russell ; 2001 ross avenue; suite 1600; dallas, TX 75201
• MDR Report Key: 18238385
• MDR Text Key: 329381477
• Report Number: 9710154-2023-00084
• 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: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

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: 21368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/30/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female