Catalog Number DWD911 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686)
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Event Date 10/21/2022 |
Event Type
Injury
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Event Description
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It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.
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Manufacturer Narrative
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The event involves a device that is not cleared for sale in the u.S., but a similar device (# dwd901) is commercially available cleared under 510k # k131231.Device is not available for evaluation as it was discarded and is not available for return.If additional information becomes available, it will be provided on a supplemental report.
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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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.
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Search Alerts/Recalls
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