Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Pain (1994); Hernia (2240); Blood Loss (2597); Not Applicable (3189); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2012 and mesh was implanted. it was reported that the patient experienced an undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Additional information.Patient code: (b)(4)- surgical intervention device code: (b)(6) - hernia recurrence occured additional narrative: it was reported that following procedure the patient experienced pain, recurrence of hernia, bleeding and erosion.It was reported that patient underwent mesh revision on (b)(6) 2013 by(b)(6) at (b)(6) due to infection.
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Manufacturer Narrative
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Date sent to fda: 06/24/2019.
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Search Alerts/Recalls
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