Catalog Number PHY1520R |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Hernia (2240); 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) 2014 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: surgical intervention.Device code: hernia recurrence occured.It was reported that the patient underwent mesh removal on (b)(6) 2017 under dr.(b)(6) at (b)(6) center due to hernia.
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Manufacturer Narrative
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In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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Manufacturer Narrative
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Date sent to fda: 6/28/2019.
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Search Alerts/Recalls
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