Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); 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 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 hernia repair surgery on (b)(6) 2010 and two (2) mesh products were implanted.It was reported that the patient underwent laparoscopic transabdominal recurrent right inguinal hernia repair surgery on (b)(6) 2018 during which the surgeon noted the mesh was found to have contracted and was adhered to cord structures, requiring surgical correction.It was reported that the patient experienced an unknown adverse event.No additional information is provided.
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Manufacturer Narrative
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Date sent to fda: 9/22/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 2/11/2021.
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Search Alerts/Recalls
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