Model Number 3346 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); Weight Changes (2607)
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Event Date 02/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2016-01252.It was reported the patient felt her extensions had become superficial after having lost weight.Surgical intervention is planned to address the issue.
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2016-01252.Follow-up identified the patient underwent surgical intervention on (b)(6) 2016 where the extensions were buried deeper.The issue has resolved following the surgical intervention.
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Search Alerts/Recalls
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