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Model Number PCDH1 |
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); Perforation (2001); Seroma (2069); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2011 during which the surgeon noted ¿the mesh was occupying the whole abdomen.The mesh was inside the whole upper abdomen.The small bowel was intimately adherent to the mesh.It took almost 2 hours to separate the small bowel from the mesh.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/19/2021.H6: appropriate term / code not available (e2402) utilized to capture infection (e19).Additional information: a1, a2, b7, d3.Additional b5 narrative: it was reported that the patient experienced recurrent ventral incisional hernia, bowel perforation, seroma and infection following surgery.
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Manufacturer Narrative
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Date sent to the fda: 10/07/2021 additional information: d4, h4 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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