Model Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994); Decreased Appetite (4569)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 01/30/2023.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 an incisional hernia repair surgery on (b)(6) 2013 and mesh was implanted.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: 3/3/2023.Additional b5 narrative: it was reported that the patient underwent laparoscopic lysis of adhesions and laparoscopic complete explant of mesh on (b)(6) 2020 due to abdominal pain, dense omental adhesions and chronic inflammation.
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Manufacturer Narrative
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Date sent to the fda: 03/07/2023.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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