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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.
 
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Brand NameDUROLANE
Type of DeviceHYALURONIC 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
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
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
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/05/2020 Patient Sequence Number: 1
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