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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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Patient weight not available for reporting date rashes began is not known.This report is for an unknown quantity of unknown pin/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that patient was implanted with synthes plates, screws, and pins in the left ankle and right knee on unknown date.On unknown date, patient presented to a clinic with rashes at the implant sites.The rashes were reported to have started approximately six (6) months post-operative and include blisters, eczematous plaques and papulous rashes.A biopsy was performed.Rashes have been treated with triamcinolone ointment.This report is for an unknown quantity of unknown pin.This is report 2 of 3 for (b)(4).
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Search Alerts/Recalls
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