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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED AB DUROLANE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameDUROLANE
Type of DeviceACID, 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 Key12196454
MDR Text Key262444078
Report Number9710154-2021-00051
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170007
Number of Events Reported1
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 Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
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 Unkown

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
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