Catalog Number HT-00005 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Urticaria (2278)
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Event Date 05/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
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Event Description
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It was reported that the patient seems to have allergic reaction to the toe tac implants.Redness and hives around the sites.Patient was revised.
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for the evaluation and no other evidence was provided.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.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.If the device is returned or 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 the patient seems to have allergic reaction to the toe tac implants.Redness and hives around the sites.Patient was revised.
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Search Alerts/Recalls
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