Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/15/2021 |
Event Type
Death
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Manufacturer Narrative
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This event is still under investigation by the manufacturing plant.A supplemental report will be submitted upon conclusion of the investigation.
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Event Description
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The fda forwarded medwatch mw5103548 to anika where it was reported by the patient's spouse that the patient expired in 2021.Exact date of death is unknown.The patient indication: bilateral post traumatic osteoarthrisis of knee.It is unknown when the patient expired after receiving an orthovisc injection.The cause of the patient's death was not provided.The patient's age and demographics was not provided.Additional information was not provided upon request.Additional information is being solicited.
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Manufacturer Narrative
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This event is still under investigation by the manufacturing plant.A supplemental report will be submitted upon conclusion of the investigation.Additional information was solicited but not provided.The lot number was not provided and additional medical information related to the patient is not available.A temporal association between the use of the device and the patient death cannot be assessed.The reported symptom will be monitored and trended for analysis.A supplemental report will be submitted upon receipt of new and relevant information.
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Event Description
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The fda forwarded medwatch mw510345 to anika where it was reported by the patient's spouse that the patient expired in 2021.Exact date of death is unknown.The patient indication: bilateral post traumatic osteoarthrisis of knee.It is unknown when the patient expired after receiving an orthovisc injection.The cause of the patient's death was not provided.The patient's age and demographics was not provided.Additional information was not provided upon request.Additional information is being solicited.
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Search Alerts/Recalls
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