Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Hernia (2240); Injury (2348); Not Applicable (3189)
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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.
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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) 2015 and mesh was implanted.It was reported by an attorney 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: 7/17/2019.Patient code: 3189- surgical intervention.Additional narrative: it was reported that the patient underwent mesh removal on (b)(6) 2016 due to pain and hernia recurrence.
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Search Alerts/Recalls
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