Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); Hernia (2240)
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2022 during which the surgeon noted the prior mesh had curled and folded in the medial and superior aspect of the mesh.Further, the mesh curled away from the pubis in the cooper ligament.The mesh dissection caused a hole to develop in the peritoneum which was closed.It was reported that the patient experienced chronic pain and nerve damage.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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Date sent to the fda: 3/20/2022.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: 5/26/2022.
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Search Alerts/Recalls
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