MalfunctionMOZ
GELSYN-3 PFS
Received Jun 19, 2020 · Event occurred Jun 8, 2020
Report MW5095139 · MDR key 10179969
Device
Product problems
- Leak/Splash
- Detachment of Device or Device Component
Patient
59 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SPONTANEOUS CONTACT FROM (B)(6) AT MD OFFICE: PRESCRIBER WAS INJECTING ONE SYRINGE INTO KNEE ON (B)(6) 2020 AND THE NEEDLE DETACHED FROM THE SYRINGE AND THE MEDICATION POURED OUT. PT DID NOT MISS A DOSE AND NO ADVERSE EFFECT WAS REPORTED; AT THE TIME OF REPORT THE DEVICE WAS AVAILABLE FOR RETURN. NO OTHER INFORMATION PROVIDED. DOSING/FREQUENCY INFORMATION: INJECT ONE SYRINGE INTRA-ARTICULARLY TO BILATERAL KNEES ONCE WEEKLY FOR 3 WEEKS AT THE PHYSICIAN'S OFFICE. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL. DATES OF USE: FROM (B)(6) 2020 TO CURRENT.