MAUDE Adverse Event Report: AMGEN USA, INC. PROLIA INJECTION; SYRINGE, PISTON

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Inflammation (1932); Pain (1994); Cough (4457)

Event Date 01/17/2023

Event Type  Injury  

Event Description

Reporter called in reference to the prolia injection for osteoporosis.She stated that the injection was extremely painful, and that after a few days, she had a low grade fever and excruciating pain in her bones where, she thought she was going to die.In conjunction with her bone pain, she developed an uncontrollable cough and had to visit urgent care (b)(6) 2023.She was prescribed antibiotics for ten days for infection and inflammation.Patient stated that she has had this injection before (every six months) but did not have the same reaction as this time, and that she will never take this injection again.

• Brand Name: PROLIA INJECTION
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): AMGEN USA, INC.
• MDR Report Key: 16399496
• MDR Text Key: 309913998
• Report Number: MW5115036
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female