Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hernia (2240); Injury (2348); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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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 procedure on (b)(6) 2011 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 08/12/2020.
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Manufacturer Narrative
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Date sent to fda: (b)(6) 2020.H6 patient code: 3189- surgical intervention.Additional information: a2, b2.Additional b5 narrative: it was reported that patient underwent revision surgery on 12/13/2012 due hernia.
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Manufacturer Narrative
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Date sent to fda: (b)(6) 2020.Additional information : d1, d2, d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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