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Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Burning Sensation (2146)
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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.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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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2018 during which the surgeon noted ¿an obvious, significantly shrunken mesh that partially adhered to the inferior epigastric vessels.The surgeon dissected the mesh off the internal oblique musculature and successfully removed the majority of the mesh, except for 3%-5% of the mesh that was adhered to the inferior epigastric vessels dep in the inguinal canal.¿ it was reported that the patient experienced excruciating pain and burning sensation in her left groin.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 3/16/2021.Additional information: a2, d3, g1, g4.
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Search Alerts/Recalls
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