Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant investigation.
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Event Description
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It was reported to anika that the device plunger flange broke when the physician was pushing the plunger of the monovisc syringe.It was reported that the physicians finger was cut from the glass.The procedure was cancelled.It is unknown if the physician required medical intervention.Additional information was solicited.
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Event Description
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It was reported to anika that the device plunger flange broke when the physician was pushing the plunger of the monovisc syringe.It was reported that the physicians finger was cut from the glass.The procedure was cancelled.It is unknown if the physician required medical intervention.Additional information was solicited.Additional information was not provided upon request.See h10 for plant investigation.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant investigation.The device was not returned to the manufacturing plant for evaluation.Additional information was not provided upon request.The batch records were reviewed.There were two non-conformances recorded in the manufacturing records.The non-conformances are not related to the reported event.This reported event will be monitored and trended for analysis.A supplemental report will be submitted upon receipt of new and relevant information.
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Search Alerts/Recalls
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