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 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.

• 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: 10556865
• MDR Text Key: 213247445
• Report Number: 9710154-2020-00077
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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 Received: 09/18/2020
• 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: 08/26/2020
• 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): Other