MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ; ACID, HYALURONIC, INTRAARTICULAR

Lot Number P17253A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Event Description

Pt reported 1 of the 3 euflexxa syringes had a different lot and expiration date than the other 2 syringes in the mfr's box; 2 pfs exp 09/08/2020, lot p17253a; 1 pfs exp 10/21/2019, lot p10006a.Lot and exp date on mfg box: exp 09/08/2020, lot p17253a.Advised that pt witnessed mdo open the intact medication box in front of him.Md has not administered any of the 3 syringes at this time.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 9328469
• MDR Text Key: 166795849
• Report Number: MW5091101
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/21/2019
• Device Lot Number: P17253A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR