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

Lot Number 20982

Device Problem Use of Device Problem (1670)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Describe event, problem, or product use error: 3 patients in the past couple weeks received injections at scott air force base medical clinic of durolane and had confirmed pseudoseptic reactions.All 3 patients were injected with the same lot (lot 20982 exp 07/31/2025).This is the first time this reaction as been observed in the 3 years this product has been in use at this location.Reference report mw5116878,mw5116879.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED AB
• MDR Report Key: 16787928
• MDR Text Key: 313863814
• Report Number: MW5116877
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 20982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose