Catalog Number PHY2025V |
Device Problem
Appropriate Term/Code Not Available (3191)
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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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(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) 2013 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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Patient code: (b)(4)-surgical intervention.Device code: (b)(4) - hernia recurrence occured.It was reported that patient underwent mesh removal on (b)(6)2014 by dr.(b)(6) at (b)(6) due to recurrent hernia.
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Manufacturer Narrative
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In addition, 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 fda: 7/16/2019.
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Search Alerts/Recalls
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