Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Swelling (2091)
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Event Type
Injury
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2.Reference mfr.Report #1627487-2017-03591.It was reported the patient presented to the er due to redness and swelling at both incision sites.Reportedly, the patient was referred to her physician for further evaluation and possible antibiotic treatment.
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Event Description
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Device 2 of 2 reference mfr.Report#1627487-2017-03591 follow-up identified infection was not confirmed and the patient's symptoms subsequently resolved.
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Search Alerts/Recalls
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