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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of dyspnoea, and the non-serious events of hypoaesthesia, hypertensive urgency, abdominal discomfort, cough and influenza like illness were considered unexpected and related to the treatment. Serious criteria include important medical event. Potential etiologies include hypersensitivity reaction given the time to onset. Alternative etiologies include community-acquired infection, guillain-barré syndrome or gbs and white coat hypertension. Potential contributory factors for cough include asthma or laryngeal edema associated with hypersensitivity reaction or ascending paralysis from gbs. Potential etiologies for hypoaesthesia include anxiety or gbs. The size of the area of numbness below the throat was unclear. The case meets the criteria for expedited reporting to the regulatory authorities. There was limited information. Follow-up information will be requested. Engineering comment (capa): 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 comment: lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by a female patient, who refers to herself (unknown age). No information about medical history, concomitant medication, history of allergies or previous filler treatments. On an unknown date, the patient received treatment with durolane to knees (unknown lot number, amount, needle type and injection technique). Within 15 minutes of leaving the doctor office, she experienced numbness up to her throat(pharyngeal hypoaesthesia) and could not breath(dyspnoea). The patient returned to the office and they checked her blood pressure and it was 224/150(hypertensive urgency), which was out of the ordinary for her. Then the patient's husband drove her to the hospital because she was having trouble breathing. The patient also had and upset stomach(abdominal discomfort), nasty couch(cough) and flu like symptoms(influenza like illness). Treatment for the adverse event was not reported. Outcome at the time of the report: could not breath was unknown. Numbness up to her throat was unknown. Blood pressure and it was 224/150 was unknown. Upset stomach was unknown. Nasty couch was unknown. Flu like symptoms was unknown.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, tx, TX 76177
• MDR Report Key: 9776197
• MDR Text Key: 192765832
• Report Number: 9710154-2020-00038
• 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: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 03/02/2020 Patient Sequence Number: 1