Catalog Number PHY1520R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Hernia (2240); 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 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) 2014 and mesh was implanted.It was reported that the patient underwent mesh removal on (b)(6) 2016 due to hernia recurrence and pain.No additional information was provided.
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Manufacturer Narrative
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A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 7/7/2021.Additional information: d3, e1.
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Search Alerts/Recalls
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