Catalog Number 33680014 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Fluid Discharge (2686)
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Event Date 09/25/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient presented 6 weeks post left total ankle replacement procedure.It was noted that there was anterior surgical wound dehiscence and serous fluid drainage.The physician completed and irrigation and debridement on october 4, 2023.The patient was treated with antibiotics.
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
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Event Description
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It was reported that the patient presented 6 weeks post left total ankle replacement procedure.It was noted that there was anterior surgical wound dehiscence and serous fluid drainage.The physician completed and irrigation and debridement on (b)(6) 2023.The patient was treated with antibiotics.
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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