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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 04-feb-2020 by a female patient, who refers to herself (unknown age).The patient had a preexisting heart condition - pvc arrhythmia with an internal heart monitor, and had previous different episodes related to her condition.The patient had previously received different injections (avian) in both knees without issues.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, the patient experienced numbness up to her throat 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 her husband drove her to the hospital because she was having trouble breathing.The patient also had an upset stomach(abdominal discomfort), nasty cough(cough) and flu like symptoms(influenza like illness).On 06-mar-2020, follow-up information was received.On that date, the patient reported that she was doing fine.She reported that 1-5 days after the durolane treatment the patient felt rough.The patient also clarified that what she experienced was not numbness or paralysis.The patient reported that she got very cold from her belly button up(feeling cold), could not catch her breath and the bp was increased.Her md thought that the act of the shot caused the bp increase.The patient went to the er and was monitored.No treatments or interventions were given except for iv saline [sodium chloride].Additionally, the patient reported that on 29-feb-2020 she had another episode with the coldness and trouble breathing like she had after getting durolane.She was just sitting on the couch, there was no trigger and she had the same symptoms.The patient went back to the er and was only monitored and did not receive any treatment.The patient had not had episodes like this before the first one after the durolane shot.Outcome at the time of the report: could not breath was recovered/resolved.Cold from her belly button up was recovered/resolved.Blood pressure and it was 224/150 was recovered/resolved.Upset stomach was recovered/resolved.Nasty couch was recovered/resolved.Flu like symptoms was recovered/resolved.Tracking list: v.0 initial report, v.1 fu received on 06-mar-2020: updated event of 'numbness up to her throat' to 'cold from her belly button up'.Added corrective treatment of iv saline.Additional information about an additional episode of the same events was received.Medical history, previous injection history and updated event outcome were provided.Galderma became aware of the follow-up information on 08-may-2020, which was sent late by bioventus.

Manufacturer Narrative

Pharmacovigilance comment: the serious event of dyspnoea, and the non-serious events of feeling cold, hypertensive urgency, abdominal discomfort, cough and influenza like illness were considered unexpected and a causal relationship to the treatment procedure could not be ruled out.Serious criteria for dyspnoea include important medical event.Potential etiologies for the events include aggravation of underlying arrhythmia secondary to white coat hypertension given the time to onset.Alternative etiologies and potential contributory factors include cardiac disorder aggravation and heart monitor defect.A community-acquired infection is less likely given the recurrence of these new symptoms later the same month in the absence of provocation or known trigger.The case meets the criteria for expedited reporting to the regulatory authorities.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.

• 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
• 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
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other