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

Lot Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious events of injection site joint effusion and hypersensitivity, and the non-serious events of pruritus and pain at injection site were considered expected and possibly related to the treatment.Seriousness criteria include medical intervention to prevent permanent damage and hospitalization.Potential root cause included the patient's hypersensitivity to the product.The case meets the seriousness 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 indicate a possible involvement of the product.Lot number was not reported and the product could not be verified.The type of incident is expected following use of the product.The information in this case does not indicate a nonconforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 26-mar-2020 by a physician which refers to a male patient aged (b)(6) years.No information about medical history, concomitant medication, history of allergies or previous treatment had been reported.On an unknown date in (b)(6) 2019, the patient received treatment with durolane in his left knee (unknown amount, lot number, injection technique and needle type).On (b)(6) 2019, the patient experienced massive knee effusion(injection site joint effusion) within 48 to 72 hours following the procedure.He required weekly knee aspirations (about 5 sessions).In (b)(6) 2019, the patient experienced burning sensation(injection site pain) and itching(injection site pruritus) all over the body about 2 weeks following the procedure.He consulted dermatologists who had concurred that it was due to the allergic reaction(hypersensitivity) to injection sodium hyluronate.The knee effusion subsided following repeated treatment with injection depomedrol.The burning and itching have subsided with low dose oral steroids (tab deflazocort 6mg).Additional clarification was received that confirmed the patient was admitted for 7 days post durolane injection and received low dose steroid at the hospital.Treatment for the adverse event included tablet deflazocort [glucocorticoids] and injection depomedrol [methylprednisolone].Outcome at the time of the report: massive knee effusion was recovered/resolved.Allergic reaction was recovered/resolved.Burning sensation was recovered/resolved.Itching was recovered/resolved.

• 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 n. freeway; fort worth, TX 76177
• MDR Report Key: 12001473
• MDR Text Key: 267840800
• Report Number: 9710154-2021-00045
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 03/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR