Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Nausea (1970); 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 laparoscopic recurrent incisional hernia repair on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted they found a prior mesh was densely adherent to the omentum and underlying bowel in the upper abdomen which required meticulous dissection to remove the mesh from the underlying structures.A small portion of the omentum was also resected using electrocautery.It was reported that the patient experienced severe pain, inflammation and nausea.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: 5/4/2022.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: 4/13/2022.Additional b5 narrative: it was reported that the patient experienced recurrent incarcerated incisional hernia following surgery.
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Search Alerts/Recalls
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