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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189)
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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 left inguinal hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2019 during which the surgeon noted on both sides, the left and right inguinal meshes were densely adherent to the cord structures.He performed tedious detaching of the mesh from the cord structures and other structures, which required extra effort and double the amount of time that is normally spent in this type of procedure.It was reported that the patient experienced chronic pain.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.Other procedure is captured in separate file.No additional information was provided.
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Search Alerts/Recalls
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