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Model Number PCDJ1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Decreased Appetite (4569)
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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) 2018 and two (2) mesh products were implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted there was found to be a recurrent hernia, extensive adhesions, multiple loops of bowel densely adherent to the previously placed mesh and a portion of the small bowel was incarcerated in the recurrent incisional hernia.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/30/2021 additional information: a1, a2, b7.
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Manufacturer Narrative
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Date sent to the fda: 1/11/2022.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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