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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Q-MED AB DUROLANE; HYALURONIC ACID
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Q-MED AB DUROLANE; HYALURONIC ACID Back to Search Results
Catalog Number 1082020
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Anaphylactic Shock (1703); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Malaise (2359)
Event Date 02/04/2020
Event Type  Injury  
Event Description
The patient received bilateral durolane injections to the knees on (b)(6) 2020 and within 15 minutes of leaving the doctor's office she had numbness up to her throat and could not breathe.She went back to the doctor's office and her blood pressure was 224/150 which was out of the ordinary for her.Then her husband drove her to the hospital because she was having trouble breathing.It was also reported that she had an upset stomach, nasty cough, and flu-like symptoms.Follow up attempts for additional information have been unsuccessful to date.
 
Event Description
The patient received bilateral durolane injections to the knees on (b)(6) 2020 and within 15 minutes of leaving the doctor's office she had numbness up to her throat and could not breathe.She went back to the doctor's office and her blood pressure was 224/150 which was out of the ordinary for her.Then her husband drove her to the hospital because she was having trouble breathing.It was also reported that she had an upset stomach, nasty cough, and flu-like symptoms.Follow up attempts for additional information have been unsuccessful to date.Upon follow up on (b)(6) 2020, the patient reported that she was doing fine.1-5 days after durolane she felt 'rough'.She clarified that what she experienced wasn't numbness or paralysis- she got very cold from her belly button up, couldn't catch her breath, bp increased.Her md thinks that the act of the shot caused bp increase.She went to the er and was watched, no treatments or interventions, just had a saline iv.Previously had different injections (avian) in both knees without issue.She has a preexisting heart condition - pvc arrhythmia - with an internal heart monitor, has had previous different episodes related to her condition.On (b)(6) 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.Went back to the er, was just watched, no treatment.Had not had episodes like this before the first one after the durolane shot.
 
Manufacturer Narrative
Based on the available information no definitive conclusions can be made if the reported events were related to the specific use of durolane.The injecting physician assessed that the reported event was most likely related to the injection procedure.There is not enough information for a definitive correlation to be made and there are other confounding variables (e.G.Pre-existing cardiac conditions, recurrence of symptoms, etc).It is unlikely that durolane would cause any type of allergic/pseudo allergic type reactions, when there was no prior reaction to previously administered avian-derived ha injections.Lot number is unknown therefore batch record review could not be performed.Attempts for additional information have been unsuccessful to date.
 
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Brand Name
DUROLANE
Type of Device
HYALURONIC ACID
Manufacturer (Section D)
Q-MED AB
seminariegatan 21
uppsala, SE-75 2 28
SW  SE-752 28,
MDR Report Key9795333
MDR Text Key196101610
Report Number3009595577-2020-00002
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 05/08/2020,03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/08/2020
Distributor Facility Aware Date02/04/2020
Event Location Other
Date Report to Manufacturer05/08/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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