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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Decreased Appetite (4569)
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Event Type
Injury
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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2009 during which the surgeon noted there were multiple areas of very adhered small bowel to the mesh.Several small serosal tears were made in the mesh.It was reported that the patient underwent recurrent hernia repair surgery on 8/3/2015.It was reported that the patient experienced severe pain, nausea, inflammation and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/19/2022.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.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
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Search Alerts/Recalls
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