Model Number PHSM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Scarring (2061); Discomfort (2330)
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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) 2012 and mesh was implanted.It was reported that the patient underwent revision surgery on an unknown date.It was reported that the patient experienced severe and chronic pain/discomfort, scarring, adhesions and mesh separation.No additional information is provided.
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Manufacturer Narrative
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Date sent to fda: 9/29/2020.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: (b)(6) 2021.Additional information: a2.
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Search Alerts/Recalls
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