Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); 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.Mwr (b)(4).Submitted for adverse event which occurred on (b)(6) 2013.Mwr (b)(4).Submitted for adverse event which occurred on (b)(6) 2015.Mwr (b)(4).Submitted for adverse event which occurred on (b)(6) 2016.
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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 hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent partial removal surgery and recurrent hernia repair surgery in (b)(6) 2015 during which the surgeon noted the small bowel was so densely adherent to the mesh, he had no choice but to remove a portion of the mesh as well as a portion of the small bowel to which it was attached.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery in (b)(6) 2016.It was reported that the patient experienced dense adhesions, small bowel obstructions and chronic intractable abdominal pain.The other procedure is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 05/06/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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