Model Number .045" GUIDE WIRE TROCAR TIP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
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Event Date 07/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported after 12 weeks post op from bunion surgery on (b)(6) 2021 the patient is experiencing swelling.Three screws were implanted and the patient feels she could be having an allergic reaction.The patient was in a hard cast for the first 30 days then to a walking boot at the 4th week.During the time right after the cast removal her foot became quite swollen and she experienced more than a moderate amount of pain.The patient elevated and iced the foot which relieved the pain to a tolerable amount but the swelling never went away.The patient is concerned she has a sensitivity to metal which could be causing this issue.
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Search Alerts/Recalls
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