MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA; ACID, HYALURONIC INTRAARTICULAR

Lot Number N10839C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 02/09/2018

Event Type  Injury  

Event Description

Pt received bilateral euflexxa intra-articular knee injections on (b)(6) 2018.Pt then presented to the clinic on (b)(6) 2018 with a swollen and painful left knee.He had a joint aspiration and was diagnosed with a left knee effusion.Culture was done on left knee joint fluid which resulted in (b)(6).Pt was subsequently placed on antibiotics (clindamycin) as an outpatient and was instructed to call if symptoms worsen.On (b)(6) 2018, the pt returned to the clinic for a f/u routine visit.The care providers did not feel any infection was present at this visit.Therefore, arthrocentesis of left knee (for joint crystals) was performed.Pt also received an intraarticular injection of a steroid into his left knee.He returned to the clinic for f/u on (b)(6) 2018 and he received the 2nd of 3 euflexxa injections for the right knee only.Pt was responding to steroid injection in the left knee and instructed to return to clinic in 1 week to finish series in right knee.Pt presented to the emergency department on (b)(6) 2018, for left knee pain and swelling and was subsequently diagnosed with a septic left knee and admitted for incision and drainage.Picc-line placement, and iv antibiotics.The results of the joint culture from the incision and drainage resulted in (b)(6).Dose or amount: 20 mg milligram(s).Frequency: 3 inj - 1 wk apart.Route: intra-articular.Therapy date: (b)(6) 2018.Diagnosis or reason for use: osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 7299538
• MDR Text Key: 101154254
• Report Number: MW5075530
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566-4100-01
• 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: 02/21/2018

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
• Device Operator: No Information
• Device Expiration Date: 11/04/2018
• Device Lot Number: N10839C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 106