MalfunctionMOZ
DUROLANE PFS
Received Jul 10, 2024
Report MW5157210 · MDR key 19722341
Device
Generic name
Acid, Hyaluronic, Intraarticular
Manufacturer
Bioventus LlcPatient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT REPORTED THAT DUROLANE SHE GOT IN (B)(6) WAS DEFECTIVE. HER MD WAS TRYING TO INJECT DUROLANE IN (B)(6) 2024 AND NOW SHE REPORTED THAT MEDICATION DID NOT GO IN, MED SPILLED OUT BEFORE IT GOT INJECTED. UNKNOWN IF PATIENT MISSED A DOSE; NO ADVERSE EVENT REPORTED; UNKNOWN IF AVAILABLE FOR RETURN; MD AWARE. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.