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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 Necrosis (1971); Pain (1994); Skin Discoloration (2074); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious event of necrosis was considered expected and possibly related to the treatment. Serious criteria included the important medical event of necrosis. The non-serious events of discoloration, pain and swelling at the injection site were considered expected and possibly related to the treatment. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation (capa comment): the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action. Manufacturer narrative: lot number was not reported.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 26-aug-2020 by a physician which refers to a patient (unspecified demographics). No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On an unknown date, the patient received treatment with durolane (lot unknown) to knee joint (bilaterally) with unknown needle and unknown technique. Soon after (not specified) the patient experienced discoloration(injection site discolouration), necrosis of the skin(injection site necrosis), pain(injection site pain) and swelling(injection site swelling). The patient contacted another physician other than the injecting physician. Not able to identify the lot number due to no access to injecting provider. Outcome at the time of the report: necrosis of the skin was not recovered/not resolved. Discoloration was not recovered/not resolved. Pain was not recovered/not resolved. Swelling was not recovered/not resolved.
 
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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 n. freeway
fort worth, TX 76177
MDR Report Key10556865
MDR Text Key213247445
Report Number9710154-2020-00077
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
Type of Report Initial
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
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 Received08/26/2020
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 Unkown

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
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