Model Number PHSM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Hernia (2240); Numbness (2415)
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Event Type
Injury
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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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted ¿the mesh was attached to the conjoined tendon.This was carefully dissected off.The dissection was continued toward the internal ring.The mesh was identified around the cord structures.Part of the mesh was adherent to the peritoneal fat as well as the inferior epigastric vessels.The mesh was carefully dissected and removed.¿ it was reported that the patient experienced severe pain, burning, nerve damage, numbness, stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 2/17/2021.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: 08/17/2021.Additional b5 narrative: it was reported that the patient experienced hernia recurrence following the surgery.
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Search Alerts/Recalls
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