MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Swelling/ Edema (4577)

Event Date 04/22/2022

Event Type  Injury  

Event Description

Reporter calling to report a problem with after she was injected with orthovisc.She states she has been receiving injections in both her knees for many years, and has never had a problem until recently.On (b)(6) 2022, she received her third series of injections in both knees but believes that the injection in her left knee was administered incorrectly because "i felt nothing at all" which she described as unusual whenever receiving these injections.The physician administering the injection was not her regular physician and was instead a substitute; she believes he administered the injection in her left knee incorrectly.After the appointment, she started feeling pain in her left knee that increased in intensity over the next two days, progressing to swelling and disrupted her sleep.She has received a cortisone injection, taken tylenol and used ice packs to treat the knee pain but has found little relief.She states the pain in her left knee is now "chronic, 24/7" and increases greatly whenever she lies down to try to sleep.She states she is meeting with her primary care physician today and will request knee imaging.

• Brand Name: ORTHOVISC INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 14288583
• MDR Text Key: 290962983
• Report Number: MW5109546
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 05/04/2022

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: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Patient Sequence Number: 1
• Treatment: CORTIZONE INJECTION; ICE PACK; TYLENOL
• Patient Outcome(s): Other
• Patient Sex: Female