MAUDE Adverse Event Report: ANIKA MONOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 03/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 it was reported that a female patient of unknown demographics experienced an anaphylactic event after receiving a lateral monovisc injection.It was reported that the patient called 911 and reported to the hospital.The patient was reportedly discharged the same day.The details of the anaphylactic event is unknown.The lot number and part number has not been reported.There was no device malfunction reported.Additional information has been solicited.

Manufacturer Narrative

This case is still under investigation.Additional information has been solicited.A supplemental report will be submitted upon receipt of additional information and or the conclusion of the investigation by the manufacturing plant.

Manufacturer Narrative

This case is still under investigation.Additional information has been solicited.A supplemental report will be submitted upon receipt of additional information and or the conclusion of the investigation by the manufacturing plant.

Event Description

On (b)(6) 2022 it was reported that a female patient of unknown demographics experienced an anaphylactic event after receiving a lateral monovisc injection.It was reported that the patient called 911 and reported to the hospital.The patient was reportedly discharged the same day.The details of the anaphylactic event is unknown.The lot number and part number has not been reported.There was no device malfunction reported.Additional information has been solicited.Supplemental report: additional information was received on 04april2022: the patient reported adverse reaction 4 weeks after the procedure.The monovisc injection occurred on or about (b)(6) 2022.A 22-gauge needle was used during the bilateral knee procedure.No other medications were used during the injection.No visual abnormalities or tampering was observed with the device or packaging.The procedure was performed with ultrasound guidance.The reported anaphylactic reaction occurred 30 minutes after the injection.The patient developed shortness of breath and throat closure consistent with anaphylactic reaction.The patient contacted 911 and was immediately provided with epinephrine and transferred to nearby hospital and discharged the same day.

Manufacturer Narrative

This case is still under investigation.Additional information has been solicited.A supplemental report will be submitted upon receipt of additional information and or the conclusion of the investigation by the manufacturing plant.The reported event is not confirmed.Additional information was not provided upon request.The surgeon did reportedly use a 22 gauge needle and the ifu recommends a 18-20 gague needle.However the cause of the reported event is unknown.A review of the device batch record was not performed due to the lot number not being reported.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

On (b)(6) 2022 it was reported that a female patient of unknown demographics experienced an anaphylactic event after receiving a lateral monovisc injection.It was reported that the patient called 911 and reported to the hospital.The patient was reportedly discharged the same day.The details of the anaphylactic event is unknown.The lot number and part number has not been reported.There was no device malfunction reported.Additional information has been solicited.Supplemental report: additional information was received on 04april2022: the patient reported adverse reaction 4 weeks after the procedure.The monovisc injection occurred on or about (b)(6) 2022.A 22-gauge needle was used during the bilateral knee procedure.No other medications were used during the injection.No visual abnormalities or tampering was observed with the device or packaging.The procedure was performed with ultrasound guidance.The reported anaphylactic reaction occurred 30 minutes after the injection.The patient developed shortness of breath and throat closure consistent with anaphylactic reaction.The patient contacted 911 and was immediately provided with epinephrine and transferred to nearby hospital and discharged the same day.Supplemental report: the patient was discharged with an epipen.Discharge summary was not provided upon request.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 13954982
• MDR Text Key: 288279140
• Report Number: 3007093114-2022-00003
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 04/15/2022
• Supplement Dates FDA Received: 04/05/2022; 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANASTROZOLE 1 MG.IBUPROFEN 800 MG.; ANASTROZOLE 1 MG.IBUPROFEN 800 MG.
• Patient Outcome(s): Other