Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Scar Tissue (2060)
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Event Type
Injury
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Manufacturer Narrative
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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) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted a lot of scar from previous hernia repair and that the spermatic cord structures could not really be completely dissected out due to all of the scar tissue.It was reported that the patient experienced extensive tissue scarring and left groin pain.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/5/2022.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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