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

Lot Number 21097

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

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 09-mar-2023 by a physician which refers to a 68-year-old female patient.Additional information was received from the same physician on 14-mar-2023 and 15-mar-2023.The medical history of the patient included knee oa issue and hypertension.No information about concomitant medication, history of allergies has been provided.The patient had previously received treatment with hylink, the product was extracted from rooster combs and no adverse reaction was reported.On (b)(6) 2023, the patient received treatment with durolane (lot 21097) to the knee joint (unknown amount, injection technique and needle type).The durolane was injected using aseptic technique and ultrasound guidance was not used.This was the first-time patient had a durolane injection.Within 5 hours after the injection, the patient's knee was swollen/fluid (injection site oedema) and painful (injection site pain) and the patient was rushed to the hospital for treatment.The patient was examined, and the intra-articular fluid was extracted which was found to have a wbc increase of up to 120.000 (synovial fluid white blood cells positive).The physician suspected that the patient might have had an infection (injection site infection) and sepsis (sepsis) problems, and the patient was hospitalized for treatment.During hospitalization, the cell culture test (for aerobic and anaerobic species) was performed three times and no infection was detected.The patient received treatment with unspecified antibiotics for 3 days.Additionally, she received treatment with unspecified anti-inflammation and pain relief medications.The hcp confirmed that no additional medical procedures were performed to treat the patient's knee after the draining procedure.On (b)(6) 2023, the wbc in the joint cavity fluid dropped to 3.000.On (b)(6) 2023, the 5th day after injection, the wbc dropped to around 1.000, and the joint cavity fluid test showed that it had returned to a clear condition.The patient improved a lot within a week.The physician reviewed some papers, references and found out that a small number of patients are allergic to hyaluronic acid which was extracted from microorganisms (streptococcus).Currently, the physician considered that the incident was caused by patient's allergy (injection site hypersensitivity) to the microorganisms.After 7 days of treatment in the hospital, the patient was recovered from events, and she was discharged from the hospital on (b)(6) 2023.Outcome at the time of the report: infection was recovered/resolved.Sepsis was recovered/resolved.Swollen/fluid was recovered/resolved.Painful was recovered/resolved.Allergy was recovered/resolved.Wbc increase of up to 120.000 was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 22-mar-2023 from same reporter.Information about past similar treatment, results of cell culture test, outcome of events and additional corrective treatment details were updated.

Manufacturer Narrative

Company comment: the serious expected events of infection at injection site, sepsis and the non-serious expected events of oedema, pain and hypersensitivity at injection site and the non-serious unexpected event of synovial fluid white blood cells positive were considered possibly related to the treatment.Seriousness criteria include the need for medical and surgical interventions, and hospitalization to prevent permanent damage.Potential root cause includes injection procedure associated with inadequate aseptic technique or patient's hypersensitivity to the product.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Evaluation text: durolane-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure or the product.The reported lot number was valid and verified the reported product.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.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.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 2001 ross avenue; suite 1600; dallas, TX 75201
• MDR Report Key: 16693328
• MDR Text Key: 312822450
• Report Number: 9710154-2023-00022
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2023

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: 21097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2022
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female