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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Hernia (2240); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2019 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery.It was reported that the patient experienced mesh migration/slippage, inflammation, severe pain and abdominal swelling.It was reported that patient had a previous hernia repair surgery on (b)(6) 2018 and mesh was implanted.Other procedure was captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/12/2021.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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