Catalog Number PHY2025V |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Adhesion(s) (1695); 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 info derived from the evaluation will be submitted in a supplemental 3500 form.
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Event Description
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It was reported by an attorney that the patient underwent a repair of an incarcerated ventral hernia on (b)(6) 2014 and mesh was implanted.On (b)(6) 2015 the patient underwent an invasive surgical procedure at (b)(6) hospital in (b)(6), for recurrence of his incarcerated large and small bowel ventral hernia and removal of the mesh.It was reported that the physician noted that the mesh was protruding into the hernia sac with omental adhesions, necessitating removal of the mesh as well as additional surgical repair of the same hernia it was implanted to treat.
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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: 7/4/2019.
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Search Alerts/Recalls
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