MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA SYR(3*2ML); ACID, HYALURONIC, INTRAARTICULAR

Lot Number V18654A

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous report.Healthcare provider from doctor's office called in to report defective euflexxa syringe.She reported one of the syringes was defective and the other two were usable.She reported the syringe was cracked and medication may have spilled out.Patient was able to complete first two weeks of injections but missed the third.No adverse event reported.Unknown if defective product available for return.No additional information provided.Indication: unilateral primary osteoarthritis, unspecified knee.Reported to cvs/caremark by health professional.

• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18994176
• MDR Text Key: 338937055
• Report Number: MW5153324
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: V18654A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1
• Patient Sex: Female