Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2017.It was reported that the patient experienced severe and chronic pain, chronic inflammation, hydrocele, mesh detachment and scarring.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 08/15/2022.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: 8/8/2022.It was reported that the patient experienced recurrent right inguinal hernia following surgery.
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Search Alerts/Recalls
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