Model Number PHSM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330)
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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) 2013 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2020 during which the surgeon noted preperitoneal space encased in chronic scar tissue which was strongly adherent to the medical aspect of the epigastric vessels.He dissected free as much of the meshoma as safely possible and repaired the recurrent hernia.It was reported that the patient experienced severe pain and discomfort.No additional information was provided.
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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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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) 2013 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2020 during which the surgeon noted preperitoneal space encased in chronic scar tissue which was strongly adherent to the medical aspect of the epigastric vessels.He dissected free as much of the meshoma as safely possible and repaired the recurrent hernia.It was reported that the patient experienced severe pain and discomfort.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/25/2022.
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Manufacturer Narrative
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Date sent to the fda: 5/9/2022.A review of the batch manufacturing records was conducted and the batch met all finished date sent to the fda.
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Search Alerts/Recalls
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