Model Number PCDG1 |
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); Weight Changes (2607)
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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.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2008.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2015.
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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) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2008 and mesh was implanted during which the surgeon noted the old mesh was identified.The hernia sac was opened and bowl was found to be adhered to the anterior abdominal wall and to the mesh.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted it was evident that the previously placed mesh was used for the prior hernia repair was anchored to the subcutaneous tissues and did not appeared to be anchored to the fascia.A segment of small bowel and omentum was densely adherent to the mesh and after he freed it up, it was beaten up pretty good.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and extreme weight loss.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: 12/14/2021.Additional b5 narrative: it was reported that the patient experienced recurrent ventral and recurrent incisional hernia following surgery.
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Manufacturer Narrative
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Date sent to the fda: 1/6/2022.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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