Catalog Number PHY1015V |
Device Problem
Appropriate Term/Code Not Available (3191)
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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 has not been 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) 2015 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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Additional information.Patient code: (b)(4) surgical intervention device code: (b)(4) - hernia recurrence additional narrative: it was reported that patient underwent repair of recurrent umbilical hernia on (b)(6) 2016 by (b)(6) at (b)(6) due to pain.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: 07/16/2019.
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Search Alerts/Recalls
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