Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Incontinence (1928); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422)
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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) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/19/2019.Additional narrative: it was reported that the patient underwent mesh revision on (b)(6) 2013 due to hernia recurrence, adhesions and incontinence.
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Manufacturer Narrative
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Date sent to fda: 1/20/2020.Additional narrative: it was reported that the patient underwent a mesh removal on (b)(6) 2015 due to small bowel obstruction.Mwr-10012020-0000648483 submitted for adverse event which occurred on (b)(6) 2013.Mwr-10012020-0000648494 submitted for adverse event which occurred on (b)(6) 2015.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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Search Alerts/Recalls
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