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

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

Patient Problems Fall (1848); Pain (1994); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The pt reported, because of her knee she fell and tore the rotator cuff.She had surgery on it 7 weeks ago and is waiting it heals to be able to have surgery on her knee.Also reports she requested another shot of rx in her knee because she is experiencing some.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED AB
• MDR Report Key: 17019857
• MDR Text Key: 316208774
• Report Number: MW5117949
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Patient Sequence Number: 1
• Treatment: LISINOPRIL TAB 40MG; NORVASC TAB 5MG; PLAQUENIL TAB 200MG; SYNVISC INJ 8MG/ML; VOLTAREN GEL 1%
• Patient Outcome(s): Other
• Patient Sex: Female