Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Swelling (2091); Hernia (2240); Obstruction/Occlusion (2422)
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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) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted the mesh was attached to the small bowel area which was dissected and separated and most of the mesh was excised and discarded.It was reported that the patient experienced severe pain, infections and swelling abdomen.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 2/16/2021.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: 2/8/2021.Additional b5 narrative: it was reported that the patient experienced recurrent incarcerated ventral hernia, obstruction and adhesions following surgery.
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Search Alerts/Recalls
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