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 Problem Stroke/CVA (1770)

Event Type  Death  

Manufacturer Narrative

Pharmacovigilance: a causal relationship between the treatment and the serious, unexpected event of cerebrovascular accident could not be ruled out.Serious criteria included death.The potential root causes for the event that might potentially be related to the treatment, including a postprocedural thromboembolic event leading to pulmonary embolism and anaphylactic shock, cannot be confirmed due to the limited information available.Underlying co-morbidities likely caused or contributed to the fatal event.Alternative root causes include the underlying medical conditions of atherosclerosis, uncontrolled hypertension, and aneurysm or angiopathy.Potential risk factors include diabetes, hypercholesterolemia, anticoagulant use, tobacco use, age and male gender.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.Routine investigations have been performed and provide sufficient information to assess the potential root cause.Lot number was not reported and the product could not be verified.No similar events of cerebrovascular accident out of (b)(4) units supplied of durolane were reported worldwide during the period 2018 through 2020.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

Case reference number (b)(4) is a spontaneous report sent on 20-jan-2021 by a physician, which refers to a male patient (unknown age).No information about medical history, concomitant medication or history of allergies.On an unknown date, the same day an injection of durolane to unknown area was performed, the patient suffered from a stroke(cerebrovascular accident) and died.It is unknown how much time had passed between the patient receiving the injection and the stroke.The cause of the patient death and any relevant co-morbidities is unknown.Lot number, amount, needle type and injection technique were not reported.Outcome at the time of the report: stroke was fatal.

• 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: 11289796
• MDR Text Key: 230613672
• Report Number: 9710154-2021-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/05/2021

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: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• 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): Death