MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 10MG/ML 2ML; ACID, HYALURONIC, INTRAARTICULAR

Lot Number NOT REPORTED

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Out bound call from (b)(6) pph who called pt in regards to schedule delivery and to obtain consent to ship to mdo for euflexx.Per pt, he reported that he has an appointment with a surgeon on (b)(6) 2021.Pt does not know if he will need medication or not yet, and asked pcc to call him back on (b)(6) 2021.(b)(6) rph advised the pt that a note will be added.(b)(6) rph also advised pt to please call (b)(6) back on (b)(6) 2021 if he does not hear from (b)(6) and to advise how he wants to proceed also while speaking with pt, he reported that he had an epidural shot recently at his neck/spin and another shot (he thinks its steroid shot) and that the euflexxa pt had worked before for him but pain came back.(b)(6) rph counselled and referred pt to mdo md: (b)(6).

• Brand Name: EUFLEXXA 10MG/ML 2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 12518600
• MDR Text Key: 273572170
• Report Number: MW5104159
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1