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Model Number 7710-X-12.0 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); Ulcer (2274)
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Event Date 12/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for evaluation.If the device becomes available as such, a follow-up report will be submitted upon completion of the evaluation.
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Event Description
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It was reported that the patient had an open sore that got infected, requiring hospitalization, while wearing the shoes.The patient received the shoes on (b)(6) 2018 and wore them the same day.After wearing the shoes for four days, the patient got an open sore that wouldn't heal and became infected.The patient was hospitalized for three days.The shoes were reportedly "half an inch bigger on the toe".
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Manufacturer Narrative
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The shoes were returned for evaluation.No fault was found with these shoes.As such, the cause of the reported event was not determined.
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Search Alerts/Recalls
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