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Model Number PHSL |
Device Problem
Migration (4003)
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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) 2018 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2021 during which the surgeon noted he encountered the mesh which he noted to have migrated to the rectus sheath.It was reported that the patient experienced severe pain, scarring, inflammation, stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Appropriate term / code not available ((b)(4)) utilized to capture mesh migration.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: 08/31/2022.Additional b5 narrative: it was reported that the patient experienced hernia recurrence.
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Search Alerts/Recalls
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